🍔 Food 💊 Drugs 🏥 Medical Devices
Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treats Frequent Heartburn, 14 capsules per bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ. 08816. NDC 16571-742-41 Class II

Reason: CGMP Deviations

NATCO Pharma Limited 20240327 Terminated
Distributed: Nationwide in the US
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Rifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad 431 210 India, NDC 6818-0659-06 Class II

Reason: Subpotent Drug

Lupin Pharmaceuticals Inc. 20240321 Terminated
Distributed: Nationwide within the United States
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FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 mL Total Volume per Vial, Intravenous, Rx Only, Hospital/Office Use Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-9010-1 Class II

Reason: Lack of Assurance of Sterility: Firm did not perform process validation.

SSM Health Care St. Louis DBA SSM St. Clare Health Center 20240229 Ongoing
Distributed: MO
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Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, Rx Only, Hospital/Office Use Only, This is a Compounded Drug - Not for Resale, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-0104-1 Class II

Reason: Lack of Assurance of Sterility: Firm did not perform process validation.

SSM Health Care St. Louis DBA SSM St. Clare Health Center 20240229 Ongoing
Distributed: MO
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Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solution, Cytotoxic Agent, After Reconstitution: For direct intravenous injection or must be further diluted before intravenous infusion, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc., Big Flats, NY 14814, NDC # 39822-0255-01. Class III

Reason: Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.

X-Gen Pharmaceuticals Inc. 20240402 Terminated
Distributed: Nationwide in the US
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Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single Dose Vial for Intravenous Use, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc. Big Flats, NY 14814, NDC # 39822-0250-01. Class III

Reason: Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.

X-Gen Pharmaceuticals Inc. 20240402 Terminated
Distributed: Nationwide in the US
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fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-6030-1 Class II

Reason: Lack of Assurance of Sterility: leaking bags

IntegraDose Compounding Services LLC 20240322 Ongoing
Distributed: Nationwide within the U.S
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Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00 Class II

Reason: Lack of assurance of sterility: bags have the potential to leak..

B. Braun Medical Inc 20240322 Terminated
Distributed: Nationwide in the USA
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Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of India, NDC 68462-562-01 Class II

Reason: Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.

Glenmark Pharmaceuticals Inc., USA 20240326 Ongoing
Distributed: Nationwide in the US
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Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL Multiple-Dose Vial, Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977. NDC: 42023-206-01 Class I

Reason: Presence of Particulate Matter.

Par Sterile Products LLC 20240304 Ongoing
Distributed: Nationwide in the USA
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