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Oxycodone Acetaminophen Tablets (Watson) – Foreign Tablets (2013)

Presence of Foreign Tablets/Capsules: 20 tablets of Oxycodone/APAP 7.5/500 mg were found in a sealed 100 count bottle of Oxycodone and Acetaminophen Tablets, USP 10/650 mg lot# 705791A.

Class IIModerate

FDASep 13, 2013Nationwide• Watson Laboratories Inc

Lamotrigine Tablets (Mylan) – Manufacturing Deviation (2013)

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Class IIModerate

FDASep 13, 2013Nationwide

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Oxycodone Acetaminophen Tablets (Watson) – Foreign Tablets (2013)

Lamotrigine Tablets (Mylan) – Manufacturing Deviation (2013)

Ifosfamide Injection 1g (AmeriSource) – Temperature Abuse (2013)

Ciprofloxacin Tablets (Mylan) – Manufacturing Deviation (2013)

Amlodipine Besylate Tablets (Mylan) – Manufacturing Deviation (2013)

Amlodipine Tablets 10mg (Mylan) – Manufacturing Deviation (2013)

Amlodipine Besylate and Benazepril HCl Capsules (Mylan) – Manufacturing Deviation (2013)

Amlodipine Besylate and Benazepril HCl Capsules (Mylan) – Manufacturing Deviation (2013)

Amlodipine Besylate Tablets (Mylan) – Manufacturing Deviation (2013)

Amlodipine Besylate and Benazepril HCl Capsules (Mylan) – Manufacturing Deviation (2013)

Amlodipine Besylate and Benazepril HCl Capsules (Mylan) – Manufacturing Deviation (2013)

Amlodipine Besylate and Benazepril HCl Capsules (Mylan) – Manufacturing Deviation (2013)

Risperdal CONSTA (Janssen) – Non-Sterility Risk (2013)

Loratadine 24 HR-OTC (Physicians Total Care) – Broken Tablets (2013)

Multi for Her (Pharmavite) – Packaging Error (2013)

HCG Premium Drops (Borinquen) – Unverified Claims (2013)

HCG Premium Cleanse Drops (Borinquen) – Unverified Claims (2013)

HCG Premium Energy Drops (Borinquen) – Unverified Claims (2013)

Multi For Him (Pharmavite) – Packaging Error (2013)

Moringa Premium Capsules (Borinquen) – Unverified Claims (2013)