🍔 Food 💊 Drugs 🏥 Medical Devices
Acyclovir Sodium Injection 1,000 mg per 20 mL* (50 mg/mL); Single Dose 20mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd, E. Windsor, NJ 08520; Made in India. NDC 55150-155-20 Class II

Reason: Presence of Particulate Matter: Customer complaint of dark particles found inside the vial

Eugia US LLC 20221228 Ongoing
Distributed: Nationwide in the USA
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Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx Only, Mfg by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Mfg for: Apotex Corp. Weston, FL 33326, NDC 60505-1005-4 Class III

Reason: Failed Stability Specifications: Out of specification for weight loss at the 18-month stability timepoint and projected weight loss of 21.1% at shelf life.

Apotex Corp. 20221221 Terminated
Distributed: USA Nationwide
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Alcohol Antiseptic 80% Topical Solution Hand Sanitizer, Non-Sterile Solution, packaged as a a) 2.5 gallon bottle (9,464 ml), NDC 55533-524-02, and b) 55 gallon bottle (208,198 ml), NDC 55533-524-03, Manufactured for: Multi-Mist Products A Division of NCH Corporation 1618 Northgate, Irving, Texas 75062 Class II

Reason: CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess of allowed limits.

NCH Life Sciences LLC 20221209 Completed
Distributed: Nationwide in United States and Canada.
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Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-363-15 Class II

Reason: Failed impurities/degradation specifications: Out of specification for unknown impurities.

AVKARE LLC 20221222 Completed
Distributed: USA Nationwide
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Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton, Rx Only, Mfd. by: THYMOORGAN PHARMAZIE GmbH, Germany, Distributed by Hikma Berkeley Heights, NJ 07922, NDC 0143-9299-01 Class II

Reason: Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.

Hikma Pharmaceuticals USA Inc. 20221216 Terminated
Distributed: USA Nationwide
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Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-558-09 Class II

Reason: CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.

Lupin Pharmaceuticals Inc. 20221207 Terminated
Distributed: Product was distributed by major distribution chains nationwide.
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Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-554-09 Class II

Reason: CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.

Lupin Pharmaceuticals Inc. 20221207 Terminated
Distributed: Product was distributed by major distribution chains nationwide.
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Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01 Class II

Reason: Failed Impurities/Degradation Specifications

Aurolife Pharma, LLC 20221216 Ongoing
Distributed: Nationwide in the USA and Puerto Rico.
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Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185-88), b) 500-count bottles (NDC 62756-185-13), c)1000-count bottles (NDC 62756-185-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India. Class II

Reason: Presence of foreign substance

SUN PHARMACEUTICAL INDUSTRIES INC 20221201 Terminated
Distributed: Nationwide within the United States
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Lacosamide Oral Solution, USP, CV, 10mg/mL, packaged in 200 mL bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured By: HETERO LABS LIMITED, Jeedimetla, Hyderabad - 500 055, India, NDC 31722-627-26 Class III

Reason: Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content

Camber Pharmaceuticals, Inc 20221206 Terminated
Distributed: USA Nationwide
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