the Compounder: 47 FDA recall reports
Every drug recall the FDA has published for the Compounder. The fault, and how the agency graded it.
47Reports
0Class I
0Ongoing
2015-11-18Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized)
D-0204-2016 · Class II · reported 2015-11-18 · Terminated
- Why it was recalled
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Product
- BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : TESTO (Testosterone USP) : DHEA (Dehydroepiandrosterone Micronized) W/V (weight/volume) VERSABASE 2.5 : 17.5 : 1.25 :0.25MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only,The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
- Where it went
- Nationwide
- How much
- 12 (10mL) syringes
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized)
D-0202-2016 · Class II · reported 2015-11-18 · Terminated
- Why it was recalled
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Product
- BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : DHEA (Dehydroepiandrosterone Micronized) IN VERSABASE W/V (weight/volume) 2.5 : 25 :1.25MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
- Where it went
- Nationwide
- How much
- 66 (10mL) syringes
BIEST TD 91/9 (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow)) : PROGESTERONE W/V (weight/volume) PL
D-0212-2016 · Class II · reported 2015-11-18 · Terminated
- Why it was recalled
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Product
- BIEST TD 91/9 (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow)) : PROGESTERONE W/V (weight/volume) PLO (Pluronic F127 20% or Polox 20% gel) 3.3 MG/ML : 40 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
- Where it went
- Nationwide
- How much
- 10 (10mL) syringes
TRIEST 80/10/10 (E1/E2 Trit - Estrone (E1)/Estradiol (E2) / Estriol USP (E3)) (23) 5MG capsules, Rx only, The
D-0227-2016 · Class II · reported 2015-11-18 · Terminated
- Why it was recalled
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Product
- TRIEST 80/10/10 (E1/E2 Trit - Estrone (E1)/Estradiol (E2) / Estriol USP (E3)) (23) 5MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
- Where it went
- Nationwide
- How much
- 120 capsules
ESTRIOL 5 ESTRADIOL (Estradiol (E2) Trit (Yellow)) 0.95 ESTRONE (Estrone E1) Trit (Red)) 0.02 TEST (Testostero
D-0225-2016 · Class II · reported 2015-11-18 · Terminated
- Why it was recalled
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Product
- ESTRIOL 5 ESTRADIOL (Estradiol (E2) Trit (Yellow)) 0.95 ESTRONE (Estrone E1) Trit (Red)) 0.02 TEST (Testosterone USP) 0.75MG/ML W/V (weight/volume) transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
- Where it went
- Nationwide
- How much
- 20 (10mL) syringes
BIEST TD 50/50 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 2.5 MG/ML tran
D-0187-2016 · Class II · reported 2015-11-18 · Terminated
- Why it was recalled
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Product
- BIEST TD 50/50 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 2.5 MG/ML transdermal cream, dispensed in 10 mL prefilled syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
- Where it went
- Nationwide
- How much
- 3 (10mL) syringes
BIEST TD 89/11 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) W/V (weight/volume) VERSABASE 2.25MG/
D-0211-2016 · Class II · reported 2015-11-18 · Terminated
- Why it was recalled
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Product
- BIEST TD 89/11 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) W/V (weight/volume) VERSABASE 2.25MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
- Where it went
- Nationwide
- How much
- 10 (3mL) syringes
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized):
D-0197-2016 · Class II · reported 2015-11-18 · Terminated
- Why it was recalled
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Product
- BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized): DHEA (Dehydroepiandrosterone Micronized) : TESTO (Testosterone Trit) W/V (weight/volume) VERSABASE 2.5: 30 : 2.5 : 0.25 MG/MLTransdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
- Where it went
- Nationwide
- How much
- 18 (10mL) syringes
BIEST TD 80/20 (estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) W/V (weight/volume) 2.5MG/ML Transd
D-0193-2016 · Class II · reported 2015-11-18 · Terminated
- Why it was recalled
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Product
- BIEST TD 80/20 (estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) W/V (weight/volume) 2.5MG/ML Transdermal cream, dispensed in a) 3 mL and b) 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
- Where it went
- Nationwide
- How much
- 30 (3mL) syringes, 9 (10mL) syringes
ESTRIOL (E3) W/V (weight/volume) VERSABASE [4714] 0.05% (0.5MG/ML) transdermal cream, dispensed in a) 1 mL an
D-0224-2016 · Class II · reported 2015-11-18 · Terminated
- Why it was recalled
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Product
- ESTRIOL (E3) W/V (weight/volume) VERSABASE [4714] 0.05% (0.5MG/ML) transdermal cream, dispensed in a) 1 mL and b) 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
- Where it went
- Nationwide
- How much
- 10 (3mL) syringes, 20 (1mL) syringes
ESTRIOL (E3) : ESTRADIOL (E2) (Estradiol (E2) Trit (Yellow)) : PROGEST (Progesterone USP) : TESTO (Testosteron
D-0218-2016 · Class II · reported 2015-11-18 · Terminated
- Why it was recalled
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Product
- ESTRIOL (E3) : ESTRADIOL (E2) (Estradiol (E2) Trit (Yellow)) : PROGEST (Progesterone USP) : TESTO (Testosterone USP) W/V (weight/volume) 2 :0.1 : 30 : 0.5 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
- Where it went
- Nationwide
- How much
- 5 (10mL) syringes
E2 (Estradiol (E2) Trit (Yellow) : E3 (Estriol USP Micronized (E3) : PROGEST (Progesterone USP Micronized) :
D-0213-2016 · Class II · reported 2015-11-18 · Terminated
- Why it was recalled
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Product
- E2 (Estradiol (E2) Trit (Yellow) : E3 (Estriol USP Micronized (E3) : PROGEST (Progesterone USP Micronized) : TESTOST (Testosterone USP) IN OLIVE OIL 0.75 : 3 : 50 : 5MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
- Where it went
- Nationwide
- How much
- 120 capsules
TRIEST 70/20/10 ( Estriol USP / Estradiol USP (E2) / Estrone (E1) Triturate) [909] 12.5MG/ML transdermal crea
D-0226-2016 · Class II · reported 2015-11-18 · Terminated
- Why it was recalled
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Product
- TRIEST 70/20/10 ( Estriol USP / Estradiol USP (E2) / Estrone (E1) Triturate) [909] 12.5MG/ML transdermal cream, dispensed in 1 mL prefilled amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
- Where it went
- Nationwide
- How much
- 24 (1mL) syringes
TRIEST 80/10/10 (Estrone (E1) Trit / Estradiol (E2) Trit / Estriol USP (E3)) 1.875MG capsules, Rx only, The Co
D-0228-2016 · Class II · reported 2015-11-18 · Terminated
- Why it was recalled
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Product
- TRIEST 80/10/10 (Estrone (E1) Trit / Estradiol (E2) Trit / Estriol USP (E3)) 1.875MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
- Where it went
- Nationwide
- How much
- 60 capsules
ESTRIOL (E3) : ESTRADIOL (E2) (Estradiol (E2) Trit (Yellow)) : PROGEST (Progesterone USP) : TESTO (Testosteron
D-0217-2016 · Class II · reported 2015-11-18 · Terminated
- Why it was recalled
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Product
- ESTRIOL (E3) : ESTRADIOL (E2) (Estradiol (E2) Trit (Yellow)) : PROGEST (Progesterone USP) : TESTO (Testosterone USP) W/V (weight/volume) 2 :0.1 : 35 : 0.5 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
- Where it went
- Nationwide
- How much
- 6 (10mL) syringes
BIEST 66/34: TESTOSTERONE : PROGESTERONE IN OLIVE OIL(Estradiol USP Micronized (ED)/Estriol USP Micronized (E3
D-0182-2016 · Class II · reported 2015-11-18 · Terminated
- Why it was recalled
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Product
- BIEST 66/34: TESTOSTERONE : PROGESTERONE IN OLIVE OIL(Estradiol USP Micronized (ED)/Estriol USP Micronized (E3): Testosterone : Progesterone in Olive Oil) 3mg : 4 mg : 100 mg/mL suspension, Rx only, packaged in a 15 mL glass dropper bottle. The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
- Where it went
- Nationwide
- How much
- 3 (15mL) bottles
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized)
D-0206-2016 · Class II · reported 2015-11-18 · Terminated
- Why it was recalled
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Product
- BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : TESTO (Testosterone USP) W/V (weight/volume) 1.25:100:0.625 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only,The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
- Where it went
- Nationwide
- How much
- 12 (10mL) syringes
BIEST 80/20 : PROGEST : DHEA : TESTOST (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow): Progesterone
D-0183-2016 · Class II · reported 2015-11-18 · Terminated
- Why it was recalled
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Product
- BIEST 80/20 : PROGEST : DHEA : TESTOST (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow): Progesterone USP: Dehydroepiandrosterone Micronized (DHEA): Testosterone Trit ) 2.5 : 25 : 2.5 : 0.1MG TROCHE, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
- Where it went
- Nationwide
- How much
- 60 troches
BIEST CP 76/24: DHEA (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow) : Dehydroepiandrosterone Micron
D-0184-2016 · Class II · reported 2015-11-18 · Terminated
- Why it was recalled
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Product
- BIEST CP 76/24: DHEA (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow) : Dehydroepiandrosterone Micronized (DHEA) 2.625 MG : 10 MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
- Where it went
- Nationwide
- How much
- 90 capsules
BIEST TD 67/33 (Estradiol (E2) TRIT (YELLOW)/Estriol USP Micronized (E3)) W/V (weight /volume) 1.5 MG/ML Trans
D-0189-2016 · Class II · reported 2015-11-18 · Terminated
- Why it was recalled
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Product
- BIEST TD 67/33 (Estradiol (E2) TRIT (YELLOW)/Estriol USP Micronized (E3)) W/V (weight /volume) 1.5 MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
- Where it went
- Nationwide
- How much
- 10 (3mL) syringes
ESTRIOL (E3) 4.0MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
D-0214-2016 · Class II · reported 2015-11-18 · Terminated
- Why it was recalled
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Product
- ESTRIOL (E3) 4.0MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
- Where it went
- Nationwide
- How much
- 90 capsules
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) W/V (weight/volume) 5 MG/ML Transde
D-0194-2016 · Class II · reported 2015-11-18 · Terminated
- Why it was recalled
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Product
- BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) W/V (weight/volume) 5 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
- Where it went
- Nationwide
- How much
- 6 (10mL) syringes
BIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 0.25 MG/ML Tra
D-0191-2016 · Class II · reported 2015-11-18 · Terminated
- Why it was recalled
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Product
- BIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 0.25 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
- Where it went
- Nationwide
- How much
- 6 (10mL) syringes
ESTRIOL (E3) : PROGESTERONE W/V (weight/volume) 4.0 : 100 MG/ML Transdermal cream, dispensed in 3 mL prefill
D-0216-2016 · Class II · reported 2015-11-18 · Terminated
- Why it was recalled
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Product
- ESTRIOL (E3) : PROGESTERONE W/V (weight/volume) 4.0 : 100 MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
- Where it went
- Nationwide
- How much
- 40 (3mL) syringes
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized)
D-0198-2016 · Class II · reported 2015-11-18 · Terminated
- Why it was recalled
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Product
- BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : DHEA (Dehydroepiandrosterone Micronized) : TESTO (Testosterone Trit) W/V (weight/volume) VERSABASE 5.0 : 30 : 2.5 : 0.25 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
- Where it went
- Nationwide
- How much
- 26 (10mL) syringes
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized)
D-0199-2016 · Class II · reported 2015-11-18 · Terminated
- Why it was recalled
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Product
- BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : DHEA (Dehydroepiandrosterone Micronized) : TESTO (Testosterone Trit) W/V (weight/volume) 2.5 : 20 : 1.25 : 0.25 MG/ML TRANSDERMAL (Cream)Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
- Where it went
- Nationwide
- How much
- 6 (10mL) syringes
ESTRIOL (E3) : TESTO (Testosterone USP) WV (weight/volume) 0.5MG : 2MG/ML Transdermal cream, dispensed in 3 mL
D-0220-2016 · Class II · reported 2015-11-18 · Terminated
- Why it was recalled
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Product
- ESTRIOL (E3) : TESTO (Testosterone USP) WV (weight/volume) 0.5MG : 2MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
- Where it went
- Nationwide
- How much
- 30 (3mL) syringes
ESTRIOL (E3) 2.5MG suppositories, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
D-0221-2016 · Class II · reported 2015-11-18 · Terminated
- Why it was recalled
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Product
- ESTRIOL (E3) 2.5MG suppositories, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
- Where it went
- Nationwide
- How much
- 20 suppositories
BIEST TD 86/14 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) IN PLO GEL (Pluronic F127 20% or Polo
D-0210-2016 · Class II · reported 2015-11-18 · Terminated
- Why it was recalled
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Product
- BIEST TD 86/14 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) IN PLO GEL (Pluronic F127 20% or Polox 20% gel) 2.9 MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only,The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
- Where it went
- Nationwide
- How much
- 20 (3mL) syringes
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : TESTO (Testosterone USP) W/V (weig
D-0207-2016 · Class II · reported 2015-11-18 · Terminated
- Why it was recalled
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Product
- BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : TESTO (Testosterone USP) W/V (weight/volume) 1.0 :4.0 MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
- Where it went
- Nationwide
- How much
- 5 (3mL) syringes
Showing the 30 most recent of 47. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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