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FDA Recalls
›Drug Recalls

FDA Drug Recalls

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

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 541–560 of 1,000 recalls

Class IITerminated

Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-081-02

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

May 15, 2023 · DrugView details →

Class IITerminated

Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-095-02

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

May 15, 2023 · DrugView details →

Class IITerminated

Ampicillin for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-088-01

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

May 15, 2023 · DrugView details →

Class IITerminated

Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-218-41

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

May 15, 2023 · DrugView details →

Class IITerminated

Ceftriaxone for Injection, USP, 1 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-096-02

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, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-214-42

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

May 15, 2023 · DrugView details →

Class IITerminated

Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-083-01

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

May 15, 2023 · DrugView details →

Class IITerminated

Ceftriaxone for Injection, USP 250 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-094-02

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

May 15, 2023 · DrugView details →

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 IITerminated

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 →

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