🍔 Food 💊 Drugs 🏥 Medical Devices
FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL Concentration - 2 mcg/mL), Rx Only, Single Dose Container, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC# 70004-0253-40 Class II

Reason: cGMP deviations: due to shipment of rejected units.

SCA Pharmaceuticals 20230720 Terminated
Distributed: KY and NJ
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Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil, Compounded Rx, For Intramuscular Use Only, a) 1 mL, b) 5 mL Multi-Dose Vial, New Vitalis Pharmacy, 4139 Cadillac Ct, Ste 201, Louisville, KY 40213 Class II

Reason: Lack of Assurance of Sterility

New Vitalis Pharmacy LLC dba New Vitalis Pharmacy 20230713 Ongoing
Distributed: Nationwide
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Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine), packaged in 4.0 FL OZ(118mL) bottles, Kramer Laboratories, Inc. Bridgewater, NJ 08807 Class II

Reason: CGMP Deviations: use of non-food grade lubricant in mixing vessel.

Kramer Laboratories, Inc. 20230623 Terminated
Distributed: nationwide within the United States
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Safe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/ Cough Suppressant Guaifenesin/Expectorant), packaged in 4.0 FL OZ(118mL), 2020 Kramer Laboratories, Inc. Bridgewater, NJ 08807 Class II

Reason: CGMP Deviations: use of non-food grade lubricant in mixing vessel.

Kramer Laboratories, Inc. 20230623 Terminated
Distributed: nationwide within the United States
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Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, Rx only, Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Manufactured by: Alembic Pharmaceuticals Limited (Derma Division) Karakhadi, Vadodara 391450, India. NDC 62332-487-12 Class II

Reason: Defective Delivery System

ALEMBIC PHARMACEUTICALS, INC. 20230622 Ongoing
Distributed: Nationwide within the United States
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Methylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bottle, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, NDC 57664-230-88. Class II

Reason: Presence of Foreign Substance: Metal embedded in a tablet.

SUN PHARMACEUTICAL INDUSTRIES INC 20230713 Terminated
Distributed: Nationwide
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Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For Intravenous Use, Rx only, packaged as a) NDC 25021-163-99 and b) novaplus NDC 25021-163-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India. Class II

Reason: Lack of Assurance of Sterility

Sagent Pharmaceuticals 20230711 Ongoing
Distributed: Nationwide in the USA
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Oxacillin for Injection, USP, 2 grams per vial, For IV or IM Use, Rx only, labeled as a) NDC 25021-162-24 and b) novaplus NDC 25021-162-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India. Class II

Reason: Lack of Assurance of Sterility

Sagent Pharmaceuticals 20230711 Ongoing
Distributed: Nationwide in the USA
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Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India. NDC 25021-146-10. Class II

Reason: Lack of Assurance of Sterility

Sagent Pharmaceuticals 20230711 Ongoing
Distributed: Nationwide in the USA
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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. Class II

Reason: 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.

Glenmark Therapeutics, Inc. 20230501 Terminated
Distributed: Nationwide in the USA
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