Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.

Class IHigh

FDAApr 21, 2014Nationwide• Hospira Inc.

Olanzapine Tablets (Apotex) – subpotent medication (2014)

Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.

Class IIILow

FDAApr 18, 2014Nationwide• Apotex Corp.

Lidocaine HCl Injection (Hospira) – iron oxide particles (2014)

Presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, identified as iron oxide, were found embedded within the glass vial and floating in solution.

Class IHigh

FDAApr 18, 2014Nationwide• Hospira Inc.

Triveen Capsules (Trigen) – incorrect vitamin labeling (2014)

Labeling: Not Elsewhere Classified: Label indicates that the product contains Vitamin B12 (12 micrograms) on the Supplement Facts panel, however, the formulation of this product does not contain Vitamin B12.

Class IIILow

FDAApr 17, 2014Nationwide• Trigen Laboratories, Inc.

Cubicin Injection (Cubist) – glass shard contamination (2014)

Presence of Particulate Matter: Customer complaint stating that one vial contained a glass shard.

Class IHigh

FDAApr 17, 2014Nationwide• Cubist Pharmaceuticals, Inc.

Pristiq Tablets (Pfizer) – foreign tablet mix-up (2014)

Presence of Foreign Tablets/Capsules: Pfizer is recalling 50 mg Pristiq (desvenlafaxine) extended release tablets because a single Pristiq 100 mg tablet was found in a bottle of 50 mg Pristiq.

Class IIModerate

FDAApr 16, 2014Nationwide• Pfizer Us Pharmaceutical Group

Super ARTHGOLD Capsules (Sung Soo Kim) – undeclared drugs (2014)

Undeclared Allergen

Marketed Without an Approved NDA/ANDA; Product contains undeclared indomethacin, diclofenac, and chlorzoxazone.

Class IHigh

FDAApr 15, 2014Nationwide• Sung Soo Kim

PhosLo GelCaps (Fresenius) – packaging contamination (2014)

Cross Contamination with Other Products: Potential for contaminant on the cotton packaging inside the bottle. Chemical analysis of the contaminant found on the cotton was identified as a formulation of 4% Trimipramine methanesulfonate - a tricyclic antidepressant..

Class IIModerate

FDAApr 14, 2014PA• Fresenius Medical Care Holdings, Inc.

Haloperidol Decanoate Injection (Fresenius) – impurity specs (2014)

Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result.

Class IIILow

FDAApr 14, 2014Nationwide• Fresenius Kabi USA LLC

Oxandrolone Tablets (Upsher Smith) – missing primary label (2014)

Labeling: Missing Label; Three cases of product (total of 36 bottles) were packaged without the primary label on the bottle. The cases were, however, packaged in the correct finished product shipper, labeled with the correct shipper bar code label, sealed with tamper-evident tape and erroneously shipped to Upsher-Smith.

Class IIILow

FDAApr 14, 2014Nationwide• Upsher Smith Laboratories, Inc.

Day Time Cold & Flu (P&L) – subpotent medication (2014)

Subpotent Drug: Phenylephrine component is subpotent.

Class IIILow

FDAApr 14, 2014Nationwide• P&L Developments, LLC

Losartan Potassium Tablets (Golden State) – cleaning debris (2014)

Presence of Foreign Substance; some bottles may contain debris that was swept up during cleaning

Class IIModerate

FDAApr 14, 2014Nationwide• Golden State Medical Supply Inc.

Metoprolol Succinate Tablets (Wockhardt) – dissolution failure (2014)

Failed Dissolution Specifications: Failure of dissolution test observed at three month time point.

Class IIModerate

FDAApr 10, 2014Nationwide• Wockhardt Usa Inc.

Muro 128 Ointment (Bausch & Lomb) – crystal precipitation (2014)

Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.

Class IIModerate

FDAApr 10, 2014Nationwide• Bausch & Lomb, Inc.

Sodium Chloride Ointment (Bausch & Lomb) – crystal formation (2014)

Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.

Class IIModerate

FDAApr 10, 2014Nationwide• Bausch & Lomb, Inc.

Gemcitabine Injection (Caraco) – sterility concern (2014)

Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance.

Class IIModerate

FDAApr 9, 2014OH• Caraco Pharmaceutical Laboratories, Ltd.

Thinogenics Weight Loss Supplement (Nature's Universe) – undeclared ingredient (2014)

Undeclared Allergen

Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine.

Class IHigh

FDAApr 9, 2014Nationwide• Nature's Universe

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