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VIVITROL Injection (Alkermes) – sterility risk (2012)

Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.

Class IIModerate

FDANov 6, 2012Nationwide• Alkermes, Inc.

Tramadol Tablets (Caraco) – foreign tablet contamination (2012)

Adulterated Presence of Foreign Tablets: A customer complaint was received that a bottle of Tramadol HCl Tablets USP 50 mg contained some tablets of Metoprolol Tartrate Tablets USP, 50 mg.

Class IIModerate

FDANov 5, 2012Nationwide

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VIVITROL Injection (Alkermes) – sterility risk (2012)

Tramadol Tablets (Caraco) – foreign tablet contamination (2012)

Pradaxa Capsules (Boehringer) – container damage (2012)

ABILIFY Tablets (Bristol Myers Squibb) – CGMP Deviation (2012)

Levothyroxine Sodium Tablets (Alara) – Subpotent Medication (2012)

Advair HFA Inhaler (GlaxoSmithKline) – Particle Distribution Issue (2012)

Advair HFA Inhaler (GlaxoSmithKline) – Particle Distribution Issue (2012)

Ultimate Formula (Zi Xiu Tang) – Undeclared Ingredient (2012)

HEXTEND Injection (Hospira) – Sterility Risk (2012)

Bee Pollen Capsule (Zi Xiu Tang) – Undeclared Ingredient (2012)

Lutera Tablets (Watson Labs) – Cross Contamination (2012)

Zenchent Tablets (Watson Labs) – Cross Contamination (2012)

Necon 1/35-28 Tablets (Watson Labs) – Cross Contamination (2012)

Necon Tablets (Watson Labs) – Cross Contamination (2012)

Zovia Tablets (Watson Labs) – Cross Contamination (2012)

Acne Pore Cleanser (Valeant) – Subpotent Ingredient (2012)

AcneFree 24 Hour Clearing System (Valeant) – Subpotent Active Ingredient (2012)

AcneFree Oil-Free Acne Cleanser (Valeant) – Subpotent Benzoyl Peroxide (2012)

Acne Astringent Pads (Valeant) – Subpotent Ingredient (2012)

AcneFree Acne Pore Cleanser (Valeant) – Subpotent Benzoyl Peroxide (2012)