thejoe Sentara Enterprises

Sentara Enterprises: 34 FDA recall reports

Every drug recall the FDA has published for Sentara Enterprises. The fault, and how the agency graded it.

34Reports

0Class I

0Ongoing

2016-02-03Most 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	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

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

Class	Reports
Class II	34

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.

Dextrose-NaCl (D5-1/2NS) in NS, Packaged in a) 1700ML Homepumps, b) 1800ML Homepumps, and c) 1920ML Homepumps

D-0620-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Product: Dextrose-NaCl (D5-1/2NS) in NS, Packaged in a) 1700ML Homepumps, b) 1800ML Homepumps, and c) 1920ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Where it went: U.S. Including: VA, NC
How much: a) 1 Bag b) 7 Bags c) 8 Bags

Lactated Ringers, Packaged in a) 1500ML Homepumps, b) 2800ML Homepumps, and c) 3600ML Homepumps, Rx Only. SENT

D-0636-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Product: Lactated Ringers, Packaged in a) 1500ML Homepumps, b) 2800ML Homepumps, and c) 3600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Where it went: U.S. Including: VA, NC
How much: a) 4 Bags b) 3 Bags c) 6 Bags

HYDROMORPHONE HCL, Packaged as a) 2.5MG in 1ML Syringes, b) 150MG in 75ML Homepumps, c) 125MG in 125ML Homepum

D-0625-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Product: HYDROMORPHONE HCL, Packaged as a) 2.5MG in 1ML Syringes, b) 150MG in 75ML Homepumps, c) 125MG in 125ML Homepumps, d) 250MG in 125ML Homepumps, e) 135MG in 135ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Where it went: U.S. Including: VA, NC
How much: a) 42 Syringes, b) 6 Bags, c) 4 Bags, d) 4 Bags, e) 1 Bag

Dextrose-5% Lactated Ringers, Packaged in 3000ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Indep

D-0643-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Product: Dextrose-5% Lactated Ringers, Packaged in 3000ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Where it went: U.S. Including: VA, NC
How much: 7 Bags

CLINDAMYCIN 120MG in NS, Package in 20ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence

D-0639-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Product: CLINDAMYCIN 120MG in NS, Package in 20ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Where it went: U.S. Including: VA, NC
How much: 6 Bags

AZACTAM (aztreonam) 2GM in NS, Packaged in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Indep

D-0638-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Product: AZACTAM (aztreonam) 2GM in NS, Packaged in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Where it went: U.S. Including: VA, NC
How much: 12 Bags

CEFAZOLIN, Packaged as a) 625MG in 6.2ML Syringes, b) 2GM in 20ML Syringes, c) 1GM in 50ML Homepumps, d) 2GM i

D-0615-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Product: CEFAZOLIN, Packaged as a) 625MG in 6.2ML Syringes, b) 2GM in 20ML Syringes, c) 1GM in 50ML Homepumps, d) 2GM in 100ML Homepumps, and e) 12GM in 600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Where it went: U.S. Including: VA, NC
How much: a) 4 Syringes, b) 49 Syringes, c) 18 Bags, d) 80 Bags, e) 23 Bags

Milrinone in 0.45% NS, Packaged as a) 52MG in 65ML Homepumps, b) 80MG in 100ML Homepumps, c) 92MG in 115ML Hom

D-0616-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Product: Milrinone in 0.45% NS, Packaged as a) 52MG in 65ML Homepumps, b) 80MG in 100ML Homepumps, c) 92MG in 115ML Homepumps, d) 104MG in 130ML Homepumps, e) 112MG in 140ML Homepumps, f) 120MG in 150ML Homepumps, g) 124MG in 155ML Homepumps, h) 128MG in 160ML, i) 136MG in 170ML Homepumps, j) 144MG in 180ML Homepumps, k) 152MG in 190ML Homepumps, l) 160MG in 200ML Homepumps, m) 172MG in 215ML Homepumps, n) 176MG in 220ML Homepumps, and o) 200MG in 250ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Where it went: U.S. Including: VA, NC
How much: a) 7, b) 4, c) 8, d) 8, e) 3, f) 4, g) 4, h) 3, i) 4, j) 4, k) 3, l) 3, m) 9, n) 6, o) 3 Bags

ASCORBIC ACID 500MG/Syringe, Packaged in 1ML Syringes, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independen

D-0627-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Product: ASCORBIC ACID 500MG/Syringe, Packaged in 1ML Syringes, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Where it went: U.S. Including: VA, NC
How much: 7 Syringes

PENICILLIN in D5W, Packaged as a)36MU in 360ML Homepumps and b) 51MU in 510ML Homepumps, Rx Only. SENTARA HOME

D-0632-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Product: PENICILLIN in D5W, Packaged as a)36MU in 360ML Homepumps and b) 51MU in 510ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Where it went: U.S. Including: VA, NC
How much: a)1 Bag, b) 4 Bags

Invanz (ertapenem) Injection Recon Soln in NS, Packaged as a) 500MG in 50ML Homepumps and b) 1 GM in 100ML Hom

D-0628-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Product: Invanz (ertapenem) Injection Recon Soln in NS, Packaged as a) 500MG in 50ML Homepumps and b) 1 GM in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Where it went: U.S. Including: VA, NC
How much: a) 3 Bags, b) 60 Bags

Solu-Cortef (hydrocortisone) 1MG in NS, Packaged in 0.1ML Syringe, Rx Only. SENTARA HOME HEALTH SENTARA RX, 53

D-0640-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Product: Solu-Cortef (hydrocortisone) 1MG in NS, Packaged in 0.1ML Syringe, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Where it went: U.S. Including: VA, NC
How much: 9 Bags

Nafcillin 2GM in NS, Packaged in 50ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkw

D-0635-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Product: Nafcillin 2GM in NS, Packaged in 50ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Where it went: U.S. Including: VA, NC
How much: 28 Bags

SOD CHLORIDE (Sodium Chloride), Packaged in a) 0.9% in 30ML Homepumps, b) 0.9% 218ML Homepumps, c) 0.45% in 50

D-0613-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Product: SOD CHLORIDE (Sodium Chloride), Packaged in a) 0.9% in 30ML Homepumps, b) 0.9% 218ML Homepumps, c) 0.45% in 500ML Homepumps, d) 0.9% in 500ML Homepumps, e) 0.9% in 1500ML Homepumps, f) 0.45% in 1920ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Where it went: U.S. Including: VA, NC
How much: a) 2 Bags, b) 1 Bags, c) 2 Bags, d) 4 Bags, e) 7 Bags f) 3 Bags

GANCICLOVIR in NS, Packaged as a) 320MG in 64ML Homepumps and b) 2440MG in 488ML Homepumps, Rx Only. SENTARA H

D-0626-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Product: GANCICLOVIR in NS, Packaged as a) 320MG in 64ML Homepumps and b) 2440MG in 488ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Where it went: U.S. Including: VA, NC
How much: a) 22 Bags, b) 3 Bags

Ampicillin/Sulbactam 12GM in NS, Packaged in 600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Ind

D-0634-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Product: Ampicillin/Sulbactam 12GM in NS, Packaged in 600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Where it went: U.S. Including: VA, NC
How much: 9 Bags

Tobramycin 120MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy

D-0642-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Product: Tobramycin 120MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Where it went: U.S. Including: VA, NC
How much: 1 Bag

MYCAMINE (micafungin sodium) 150MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535

D-0644-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Product: MYCAMINE (micafungin sodium) 150MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Where it went: U.S. Including: VA, NC
How much: 10 Bags

ZOSYN (pipericillin/tazobactam) in NS, Packaged as a) 3.375GM in 50ML Homepumps, b) 4.5GM in 100ML Homepumps,

D-0630-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Product: ZOSYN (pipericillin/tazobactam) in NS, Packaged as a) 3.375GM in 50ML Homepumps, b) 4.5GM in 100ML Homepumps, c) 18GM in 267ML Homepumps, d) 27GM in 400ML Homepumps, and e) 36GM in 533ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Where it went: U.S. Including: VA, NC
How much: a) 56 Bags b) 28 Bags c) 4 Bags, d) 10 Bags e) 2 Bags

VANCOMYCIN HCL, Packaged as: a) 600MG in 120ML Homepumps, b) 750MG in 150ML Homepumps, c) 850MG in 170ML Homep

D-0623-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Product: VANCOMYCIN HCL, Packaged as: a) 600MG in 120ML Homepumps, b) 750MG in 150ML Homepumps, c) 850MG in 170ML Homepumps, d) 1GM in 200ML Homepumps, e) 1.25GM in 250ML Homepumps, f) 1.5GM in 300ML Homepumps, g) 1.75GM in 350ML Homepumps, h) 2GM in 400ML Homepumps, i) 4000MG in 800ML Homepumps, j) 5000MG in 1000ML Homepumps, k) 6GM in 1200ML Homepumps, l) 7.5GM in 1500ML Homepumps, and m) 9000MG in 1800ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Where it went: U.S. Including: VA, NC
How much: a) 12 Bags, b) 36 Bags, c) 8 Bags, d) 65 Bags, e) 18 Bags, f) 36 Bags g) 21 Bags, h) 7 Bags, i) 3 Bags, j) 3 Bags, k) 2 Bags, l) 6 Bags, m) 3 Bags

Cancidas (caspofungin acetate) 58.4MG in NS, Packaged in 116.8ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTA

D-0637-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Product: Cancidas (caspofungin acetate) 58.4MG in NS, Packaged in 116.8ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Where it went: U.S. Including: VA, NC
How much: 7 Bags

SOLUMEDROL (methylprednisolone succinate) 1GM in NS, Packaged in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH

D-0617-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Product: SOLUMEDROL (methylprednisolone succinate) 1GM in NS, Packaged in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Where it went: U.S. Including: VA, NC
How much: 7 Bags

DOBUTAMINE HCL in D5W, Packaged as a) 240MG in 60ML Homepumps and b) 1520MG in 380ML Homepumps, Rx Only. SENTA

D-0622-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Product: DOBUTAMINE HCL in D5W, Packaged as a) 240MG in 60ML Homepumps and b) 1520MG in 380ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Where it went: U.S. Including: VA, NC
How much: a) 7 Bags, b) 4 Bags

GENTAMICIN, Packaged as a) 70MG in 70ML Homepumps, b) 80MG in 80ML Homepumps, and c) 375MG in a 75ML Homepumps

D-0641-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Product: GENTAMICIN, Packaged as a) 70MG in 70ML Homepumps, b) 80MG in 80ML Homepumps, and c) 375MG in a 75ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Where it went: U.S. Including: VA, NC
How much: a) 11 bags, b) 9 Bags, c) 3 Bags

INTRALIPID (fat emulsion), Packaged in a) 27ML Homepumps, b) 125ML Homepumps, c) 1800ML Homepumps, d) 2000ML H

D-0618-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Product: INTRALIPID (fat emulsion), Packaged in a) 27ML Homepumps, b) 125ML Homepumps, c) 1800ML Homepumps, d) 2000ML Homepumps e) 2350ML Homepumps, and f) 2800ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Where it went: U.S. Including: VA, NC
How much: a) 7 Bags, b) 1 Bag, c) 7 Bags, d) 6 Bags e) 7 Bags, f) 7 Bags

Parenteral Amino Acid Infusion 10%, Packaged in a) 780ML Homepumps, b) 1000ML Homepumps, c) 1140ML Homepumps,

D-0614-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Product: Parenteral Amino Acid Infusion 10%, Packaged in a) 780ML Homepumps, b) 1000ML Homepumps, c) 1140ML Homepumps, d) 1152ML Homepumps, e) 1400ML Homepumps, f) 1440ML Homepumps, g) 1500ML Homepumps, h) 1700ML Homepumps, i) 1900ML Homepumps, j) 2130ML Homepumps, k) 2250ML Homepumps, l) 2400ML Homepumps, m) 2650ML Homepumps, n) 2700ML Homepumps, o) 3250ML Homepumps, p) 3390ML Homepumps, and q) 3500ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Where it went: U.S. Including: VA, NC
How much: a) 7, b) 7, c) 6, d) 7, e) 4, f) 13, g) 2, h) 4, i) 7, j) 5, k) 10, l) 11, m) 11, n) 11, o) 7, p) 7, q) 7 Bags

MEROPENEM in NS, Packaged as a) 1000MG in 250ML Homepumps, and b) 2GM in 100ML Homepumps, Rx Only. SENTARA HOM

D-0611-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Product: MEROPENEM in NS, Packaged as a) 1000MG in 250ML Homepumps, and b) 2GM in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Where it went: U.S. Including: VA, NC
How much: a) 159 Bags b) 33 Bags

ONDANSETRON HCL 8MG, Packaged in 100ML Homepumps. Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pk

D-0624-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Product: ONDANSETRON HCL 8MG, Packaged in 100ML Homepumps. Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Where it went: U.S. Including: VA, NC
How much: 77 Bags

CEFEPIME, Packaged a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepumps, and c) 12GM in 600ML Homepumps, Rx Onl

D-0629-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Product: CEFEPIME, Packaged a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepumps, and c) 12GM in 600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Where it went: U.S. Including: VA, NC
How much: a) 21 Bags, b) 26 Bags c) 3 Bags

POTASSIUM CHLORIDE in D 5 1/2NS, Packaged in a) 40 mEq KCL/LITER 1000ML Homepumps and b) 160 mEq KCL/LITER 500

D-0619-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Product: POTASSIUM CHLORIDE in D 5 1/2NS, Packaged in a) 40 mEq KCL/LITER 1000ML Homepumps and b) 160 mEq KCL/LITER 500ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Where it went: U.S. Including: VA, NC
How much: a) 7 Bags, b) 2 Bags

Showing the 30 most recent of 34. 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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