thejoe KRS Global Biotechnology, Inc

KRS Global Biotechnology, Inc: 129 FDA recall reports

Every drug recall the FDA has published for KRS Global Biotechnology, Inc. The fault, and how the agency graded it.

129Reports

0Class I

0Ongoing

2019-10-09Most 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	129

By year reported

Year	Reports
2018	47
2019	82

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.

GLYCOpyrrolate (PF) 0.6 mg/3 mL (0.2 mg/mL) in 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791

D-0054-2020 · Class II · reported 2019-10-09 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: GLYCOpyrrolate (PF) 0.6 mg/3 mL (0.2 mg/mL) in 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC3321678316
Where it went: Nationwide
How much: 10630 syringes

NEOstigmine Methylsulfate (PF), 5 mg/5 mL (1 mg/mL), 5 mL fill in a 6 mL Single Dose Syringe, Rx Only, KRS Glo

D-0078-2020 · Class II · reported 2019-10-09 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: NEOstigmine Methylsulfate (PF), 5 mg/5 mL (1 mg/mL), 5 mL fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678303
Where it went: Nationwide
How much: 3410 syringes

Quadmix # 19 (Prostaglandin E1-0.75 mg / Papaverine HCl-150 mg / Phentolamine Mesylate-15 mg / Atropine Sulfat

D-0092-2020 · Class II · reported 2019-10-09 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Quadmix # 19 (Prostaglandin E1-0.75 mg / Papaverine HCl-150 mg / Phentolamine Mesylate-15 mg / Atropine Sulfate Monohydrate-1.5 mg/vial), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678383
Where it went: Nationwide
How much: 95 vials

Sermorelin, 3 mg / GHRP-2, 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of

D-0100-2020 · Class II · reported 2019-10-09 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Sermorelin, 3 mg / GHRP-2, 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674092
Where it went: Nationwide
How much: 120 vials

Vitamin 9A/B Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca R

D-0114-2020 · Class II · reported 2019-10-09 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Vitamin 9A/B Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678339
Where it went: Nationwide
How much: 6325 vials

Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 10% (100 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac T

D-0116-2020 · Class II · reported 2019-10-09 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 10% (100 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac Tromethamine 0.5% (5 mg/mL), Sterile Ophthalmic Topical Solution, 5 mL Fill in a 7 mL Droptainer,Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676223
Where it went: Nationwide
How much: 242 droptainers

L-Carnitine 27 mL Fill in a 30 mL Vial, For Dilution Use Only, 2,025 mg/27 mL (75 mg/mL) Rx Only, KRS Global B

D-0045-2020 · Class II · reported 2019-10-09 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: L-Carnitine 27 mL Fill in a 30 mL Vial, For Dilution Use Only, 2,025 mg/27 mL (75 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676396
Where it went: Nationwide
How much: 6447 vials

NEOstigmine Methylsulfate (PF), 3 mg/3 mL (1 mg/mL), 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnolo

D-0077-2020 · Class II · reported 2019-10-09 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: NEOstigmine Methylsulfate (PF), 3 mg/3 mL (1 mg/mL), 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677847
Where it went: Nationwide
How much: 7685 syringes

Ascorbic Acid (Tapioca Source) 25 g/50 mL (0.5 g/mL) 50 mL Vial--For SC/IM Use-Contains Sulfites, Rx Only, KRS

D-0041-2020 · Class II · reported 2019-10-09 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Ascorbic Acid (Tapioca Source) 25 g/50 mL (0.5 g/mL) 50 mL Vial--For SC/IM Use-Contains Sulfites, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321675033
Where it went: Nationwide
How much: 602 vials

Hydroxocobalamin 30 mg/30 mL (1 mg/mL) 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Co

D-0063-2020 · Class II · reported 2019-10-09 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Hydroxocobalamin 30 mg/30 mL (1 mg/mL) 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678334
Where it went: Nationwide
How much: 345 vials

Isoproterenol HCL (PF) in D5W, 200 mcg / 50 mL (4 mcg/mL), 50 mL IV Bag, Single Dose Only, Contains Sulfites,

D-0118-2020 · Class II · reported 2019-10-09 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Isoproterenol HCL (PF) in D5W, 200 mcg / 50 mL (4 mcg/mL), 50 mL IV Bag, Single Dose Only, Contains Sulfites, For Slow IV use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677610
Where it went: Nationwide
How much: N/A

Phenylephrine HCl 1.5% (15 mg/mL) Lidocaine HCl 1% (10 mg/mL) (PF) (Sulfite Free) Ophthalmic Injection, 3 mL S

D-0084-2020 · Class II · reported 2019-10-09 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Phenylephrine HCl 1.5% (15 mg/mL) Lidocaine HCl 1% (10 mg/mL) (PF) (Sulfite Free) Ophthalmic Injection, 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678441
Where it went: Nationwide
How much: 825 syringe

NORepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bag, 4 mg/250 mL (0.016 mg/mL), Rx Only, KRS Global Bi

D-0080-2020 · Class II · reported 2019-10-09 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: NORepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bag, 4 mg/250 mL (0.016 mg/mL), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487, NDC 3321678032
Where it went: Nationwide
How much: 528 bags

Sodium Citrate 40 mg/mL (4%) / Gentamicin 0.32 mg/mL. 30 mL vial for Intra-Catheter Use Only, Rx Only, KRS Glo

D-0102-2020 · Class II · reported 2019-10-09 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Sodium Citrate 40 mg/mL (4%) / Gentamicin 0.32 mg/mL. 30 mL vial for Intra-Catheter Use Only, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676603
Where it went: Nationwide
How much: 150 vials

Sodium Bicarbonate 8.4%, 4,200 mg / 50 mL 50 mEq / 50 mL (84 mg/mL) (1 mEq/mL), 50 mL Fill in a 60 mL Single D

D-0101-2020 · Class II · reported 2019-10-09 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Sodium Bicarbonate 8.4%, 4,200 mg / 50 mL 50 mEq / 50 mL (84 mg/mL) (1 mEq/mL), 50 mL Fill in a 60 mL Single Dose Syringe, For IV Use, Rx Only KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674199
Where it went: Nationwide
How much: 540 syringes

Bacteriostatic Water for Injection, 30 mL Vial, Rx Only, KRS Global Biotechnology791 Park of Commerce Blvd, Bo

D-0042-2020 · Class II · reported 2019-10-09 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Bacteriostatic Water for Injection, 30 mL Vial, Rx Only, KRS Global Biotechnology791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674177
Where it went: Nationwide
How much: 6568 vials

Sermorelin Acetate 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce

D-0098-2020 · Class II · reported 2019-10-09 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Sermorelin Acetate 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321601122
Where it went: Nationwide
How much: 64 vials

Labetalol HCl 5 mg/mL 20 mg/4 mL (5 mg/mL) 4 mL Fill in a 6 mL Single Dose Syringe, Rx only, KRS Global Biotec

D-0066-2020 · Class II · reported 2019-10-09 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Labetalol HCl 5 mg/mL 20 mg/4 mL (5 mg/mL) 4 mL Fill in a 6 mL Single Dose Syringe, Rx only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676419
Where it went: Nationwide
How much: 6405 syringes

LIDOcaine HCl 0.75%(7.5 mg/mL)/ EPINRPHrine 0.025% (0.25 mg/mL) (PF) (Sulfite Free) in BSS, 1 mL Fill in a 3 m

D-0067-2020 · Class II · reported 2019-10-09 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: LIDOcaine HCl 0.75%(7.5 mg/mL)/ EPINRPHrine 0.025% (0.25 mg/mL) (PF) (Sulfite Free) in BSS, 1 mL Fill in a 3 mL Single Dose Syringe, Rx only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678395
Where it went: Nationwide
How much: 4105 syringes

Hydroxocobalamin 10 mL Vial 5 mg/10 mL (0.5 mg/mL) For IM Use, Rx Only, KRS Global Biotechnology 791 Park of C

D-0061-2020 · Class II · reported 2019-10-09 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Hydroxocobalamin 10 mL Vial 5 mg/10 mL (0.5 mg/mL) For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678336
Where it went: Nationwide
How much: 1528

PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 100 mg / 250 mL (0.4 mg/mL), 250 mL Single-

D-0087-2020 · Class II · reported 2019-10-09 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 100 mg / 250 mL (0.4 mg/mL), 250 mL Single-Dose Bag For IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678039
Where it went: Nationwide
How much: 228 bags

Polidocanol 5%, 500 mg / 10 mL (50 mg/mL), 10 mL Vial for IV Use, Rx Only, KRS Global Biotechnology 791 Park o

D-0090-2020 · Class II · reported 2019-10-09 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Polidocanol 5%, 500 mg / 10 mL (50 mg/mL), 10 mL Vial for IV Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677749
Where it went: Nationwide
How much: 317 vials

Methionine 750 mg / Inositol 1,500 mg / Choline Chloride 1,500 mg / Pyridoxine HCl 1,500 mg / Cyanocobalamin 3

D-0072-2020 · Class II · reported 2019-10-09 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Methionine 750 mg / Inositol 1,500 mg / Choline Chloride 1,500 mg / Pyridoxine HCl 1,500 mg / Cyanocobalamin 30 mg Lyophilized, Vial For IM Use, Rx Only KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321675952
Where it went: Nationwide
How much: 497 vials

Fluorescein (PF) Lyophilized-For IV Use, Single Dose Vial, 500 mg/vial, Rx Only, KRS Global Biotechnology 791

D-0052-2020 · Class II · reported 2019-10-09 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Fluorescein (PF) Lyophilized-For IV Use, Single Dose Vial, 500 mg/vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676632
Where it went: Nationwide
How much: 1980 vials

Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac T

D-0108-2020 · Class II · reported 2019-10-09 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac Tromethamine 0.5% (5 mg/mL), 3 mL Droptainer, Sterile Ophthalmic Topical Solution, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676225
Where it went: Nationwide
How much: 649 droptainers

Human Chorionic Gonadotropin 6,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 79

D-0059-2020 · Class II · reported 2019-10-09 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Human Chorionic Gonadotropin 6,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673969
Where it went: Nationwide
How much: 2263 vials

fentaNYL Citrate in 0.9% Sodium Chloride (PF) 1,000 mcg/100 mL (10 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx On

D-0049-2020 · Class II · reported 2019-10-09 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: fentaNYL Citrate in 0.9% Sodium Chloride (PF) 1,000 mcg/100 mL (10 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 33216282300
Where it went: Nationwide
How much: 492 bags

Hyaluronidase (PF) Ophthalmic Injection 450 Units/3 mL (150 Units/mL) 3 mL Fill in a 5 mL Single Dose Vial, Rx

D-0060-2020 · Class II · reported 2019-10-09 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Hyaluronidase (PF) Ophthalmic Injection 450 Units/3 mL (150 Units/mL) 3 mL Fill in a 5 mL Single Dose Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678359
Where it went: Nationwide
How much: 928 vials

Human Chorionic Gonadotropin 20,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology79

D-0057-2020 · Class II · reported 2019-10-09 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Human Chorionic Gonadotropin 20,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673977
Where it went: Nationwide
How much: 1871 vials

Vitamin B1/B2/B3/B6/HYDROXOCOBALAMIN 66/1.33/66/66/0.66 mg/mL (PF), For IV Use, 3 mL fill in a 5 mL Single Dos

D-0115-2020 · Class II · reported 2019-10-09 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Vitamin B1/B2/B3/B6/HYDROXOCOBALAMIN 66/1.33/66/66/0.66 mg/mL (PF), For IV Use, 3 mL fill in a 5 mL Single Dose Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678335
Where it went: Nationwide
How much: 948 vials

Showing the 30 most recent of 129. 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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