🍔 Food 💊 Drugs 🏥 Medical Devices
PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-932-33, UPC 3 69374-93233 2. Class II

Reason: CGMP Deviations: Potential for cross contamination due to product carry over.

Nephron Sterile Compounding Center LLC 20221110 Terminated
Distributed: Nationwide in the USA
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PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-946-34, UPC 3 69374 94634 6. Class II

Reason: CGMP Deviations: Potential for cross contamination due to product carry over.

Nephron Sterile Compounding Center LLC 20221110 Terminated
Distributed: Nationwide in the USA
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Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharmaceuticals Inc. Morgantown, WV 36505, Made in India, NDC 0378-3634-05 Class II

Reason: Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness.

Viatris Inc 20221021 Terminated
Distributed: Nationwide in the USA
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0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37 Class II

Reason: Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.

ICU Medical Inc 20221109 Ongoing
Distributed: Nationwide in the USA
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Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottles, RX only Dist. by: Par Pharmaceutical Chestnut Ridge, NY 10977 U.S.A. Mfg. by: Par Forumulations Private Limited,9/215, Pudupakkam, Kelambakkam - 603 103. NDC 49884-038-01 Class II

Reason: Failed Impurities/Degradation Specifications

Par Formulations Private Limited 20221110 Terminated
Distributed: Nationwide within the United States
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Timolol-Latanoprost (0.5/0.005%) ophthalmic drops, Compounded, 5 mL bottle, Imprimis Rx, Ledgewood, NJ. Class II

Reason: Subpotent Drug: The batches contain less than 90% of the labeled amount of latanoprost.

ImprimisRx NJ 20221109 Terminated
Distributed: Nationwide in the USA
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Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound), 100 mg per vial, NDC 80803-153-50, manufactured for Aadi Bioscience, Inc, CA. Class III

Reason: Failed Stability Specifications

Aadi Bioscience 20221013 Terminated
Distributed: Within the U.S Market - PA, AL, KY, TN
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Octreotide Acetate Injection 500 mcg/mL, 10 x 1 mL Single-Dose Unit-of-Use Syringes, For Subcutaneous or Intravenous Use, Rx Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505 U.S.A., Made in Italy, NDC: 67457-246-00 (syringe), 67457-246-01 (carton). Class I

Reason: Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.

Viatris Inc 20221007 Terminated
Distributed: Nationwide in the USA
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VORICONAZOLE OPTH SOLUTION 2% STERILE SOLN, 10 ML droptainer, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 Class II

Reason: Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.

Pharmacy Plus, Inc. dba Vital Care Compounder 20221007 Ongoing
Distributed: AL, LA, MS, and TN
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VANCOMYCIN INTRAVITREAL 1MG/0.1ML SOLUTION, 0.5 mL syringes, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 Class II

Reason: Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.

Pharmacy Plus, Inc. dba Vital Care Compounder 20221007 Ongoing
Distributed: AL, LA, MS, and TN
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