🍔 Food 💊 Drugs 🏥 Medical Devices
Ampicillin for Injection, USP, 250 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-084-02 Class II

Reason: Lack of Assurance of Sterility

Astral SteriTech Private Ltd. 20230515 Terminated
Distributed: Nationwide within the United States
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Ampicillin for Injection, USP 10 g per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-224-15 Class II

Reason: Lack of Assurance of Sterility

Astral SteriTech Private Ltd. 20230515 Terminated
Distributed: Nationwide within the United States
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Ampicillin for Injection, USP 2g per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-223-41 Class II

Reason: Lack of Assurance of Sterility

Astral SteriTech Private Ltd. 20230515 Terminated
Distributed: Nationwide within the United States
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Ampicillin for Injection, USP 1g per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-222-41 Class II

Reason: Lack of Assurance of Sterility

Astral SteriTech Private Ltd. 20230515 Terminated
Distributed: Nationwide within the United States
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Ampicillin for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-221-41 Class II

Reason: Lack of Assurance of Sterility

Astral SteriTech Private Ltd. 20230515 Terminated
Distributed: Nationwide within the United States
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Ampicillin for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-220-41 Class II

Reason: Lack of Assurance of Sterility

Astral SteriTech Private Ltd. 20230515 Terminated
Distributed: Nationwide within the United States
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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, Class II

Reason: Subpotent: Low anti-factor IIa Potency.

B. Braun Medical Inc 20230509 Terminated
Distributed: Nationwide in the USA
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Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, NDC # 70518-2534-01; b) 1 x 100 UD box, NDC # 70518-2534-00, MFG: Akorn, Lake Forest, IL 60045, Repackaged by : RemedyRepack Inc., PA 15701. Mfg NDC # 61748-0012-01 Class II

Reason: 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.

RemedyRepack Inc. 20230501 Ongoing
Distributed: Product was distrituded to three direct account in PA.
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Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, Lake Forrest IL 60045, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1142-00; Source NDC # 17477-0717-10; Class II

Reason: 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.

RemedyRepack Inc. 20230501 Ongoing
Distributed: Product was distrituded to three direct account in PA.
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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 Class II

Reason: 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.

RemedyRepack Inc. 20230501 Terminated
Distributed: Product was distrituded to three direct account in PA.
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