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  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 541–560 of 1,000 recalls

Class IITerminated

Cefepime for Injection, USP 1 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-057-10

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

May 15, 2023 · DrugView details →
Class IITerminated

Ceftriaxone for Injection, USP, 2 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-097-02

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

May 15, 2023 · DrugView details →
Class II
Terminated

Ampicillin for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-221-41

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

May 15, 2023 · DrugView details →
Class IITerminated

Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-215-15

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

May 15, 2023 · DrugView details →
Class IITerminated

Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-082-02

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

May 15, 2023 · DrugView details →
Class IITerminated

Cefepime for Injection, USP 2 grams per vial, Rx only, Mfg. for: Piramal Critical Care Bethlehem, PA 18017 USA, NDC 66794-210-41

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

May 15, 2023 · DrugView details →
Class IITerminated

Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-003-31

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

May 15, 2023 · DrugView details →
Class IITerminated

Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-002-31

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

May 15, 2023 · DrugView details →
Class IITerminated

Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Vials per carton (NDC 0641-6044-25), Rx only, Manufactured by West-Ward, Eatontown, NJ 07724.

Hikma Pharmaceuticals USA Inc.

Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.

May 11, 2023 · DrugView details →
Class IITerminated

Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dextrose injection, 250 ml Excel Container, B. Braun Medical Inc. Bethlehem, PA 18018, USA; API from Spain NDC: 0264-9587-20,

B. Braun Medical Inc

Subpotent: Low anti-factor IIa Potency.

May 9, 2023 · DrugView details →
Class IITerminated

buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceutical Industries Limited, Gujrat, India, NDC 47335-737-86

SUN PHARMACEUTICAL INDUSTRIES INC

Failed Dissolution Specifications; during stability testing

May 9, 2023 · DrugView details →
Class IITerminated

Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83.

SUN PHARMACEUTICAL INDUSTRIES INC

CGMP Deviations

May 3, 2023 · DrugView details →
Class IITerminated

Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Made in India, NDC 72657-113-20.

Glenmark Therapeutics, Inc.

Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating strength as 10 mg.

May 1, 2023 · DrugView details →
Class IITerminated

LORazepam Injection, 2mg / mL Single Dose vial 1ml vial, Rx Only, MFG Akorn Lake Forest IL 60045, Repackaged by: RemedyRepack Inc., Indiana PA 15701, Source NDC # 17478-0040-01, Remedy NDC 70518-2268-00

RemedyRepack Inc.

CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

May 1, 2023 · DrugView details →
Class IITerminated

vasopressin 20 units added to 0.9% sodium chloride 100 mL*, 0.2 units/mL*, 100 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-9000-1.

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

April 28, 2023 · DrugView details →
Class IITerminated

Cardioplegia Solution, Maintenance 4:1 Plasma-Lyte/Tromethamine, low potassium, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0112-1.

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

April 28, 2023 · DrugView details →
Class IITerminated

Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10%, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0406-1.

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

April 28, 2023 · DrugView details →
Class IITerminated

Cardioplegia Solution, Warm Induction 4:1 HIGH POTASSIUM/low tromethamine, 40 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0011-1.

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

April 28, 2023 · DrugView details →
Class IITerminated

MSA 7.84% MSG 8.56% (0.92M) Comp. Sol. 1000 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8029-1, code 7128580291.

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

April 28, 2023 · DrugView details →
Class IITerminated

vancomycin added to 0.9% sodium chloride, 2 g/500 mL* (4 mg/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6078-1.

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

April 28, 2023 · DrugView details →
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