🍔 Food 💊 Drugs 🏥 Medical Devices
Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA, UPC 5140782430, NDC 51407-824-30 Class II

Reason: Failed Dissolution Specifications

Golden State Medical Supply Inc. 20240112 Terminated
Distributed: Illinois only
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Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 0591-2510-30 Class II

Reason: Failed Dissolution Specifications

Teva Pharmaceuticals USA, Inc 20240108 Ongoing
Distributed: Nationwide
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Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by:Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01 Class II

Reason: Failed Impurities/Degradation Specifications

Lupin Pharmaceuticals Inc. 20240103 Terminated
Distributed: Nationwide in the USA
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Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramine HCl 25mg), 8 FL OZ (237 mL) bottle, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059 Class I

Reason: Microbial Contamination of Non-Sterile Products

Haleon US Holdings LLC 20231226 Terminated
Distributed: USA nationwide
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Robitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, Dextromethorphan HBr 20 mg), a) 4 FL OZ (118mL) and b) 8 FL OZ (237 mL) bottles, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059 Class I

Reason: Microbial Contamination of Non-Sterile Products

Haleon US Holdings LLC 20231226 Terminated
Distributed: USA nationwide
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Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per bottle, NDC 51660-998-30; Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India, b) 45 Tablets per bottle, NDC 51316-800-45; Distributed by: CVS Pharmacy, Inc., Woonsocket, RI 02895, Made in India, c) 150 Tablets per bottle, NDC 51660-998-55, Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India. Class II

Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

SUN PHARMACEUTICAL INDUSTRIES INC 20240118 Completed
Distributed: Nationwide in the USA
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Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA, NDC 47335-308-88. Class II

Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

SUN PHARMACEUTICAL INDUSTRIES INC 20240118 Completed
Distributed: Nationwide in the USA
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Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA, NDC 47335-307-88. Class II

Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

SUN PHARMACEUTICAL INDUSTRIES INC 20240118 Completed
Distributed: Nationwide in the USA
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Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-539-81. Class II

Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

SUN PHARMACEUTICAL INDUSTRIES INC 20240118 Completed
Distributed: Nationwide in the USA
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Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-613-81. Class II

Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

SUN PHARMACEUTICAL INDUSTRIES INC 20240118 Completed
Distributed: Nationwide in the USA
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