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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.

Tikosyn Capsules (Pfizer) – foreign tablet detected (2014)

Presence of Foriegn Tablets/Capsules: A single Tikosyn¿ (dofetilide) 250 mcg capsule was discovered in one bottle of Tikosyn¿ (dofetilide) 500 mcg (0.5 mg).

Class IIModerate

FDAApr 8, 2014Nationwide• Pfizer Inc.

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Gemcitabine Injection (Caraco) – sterility concern (2014)

Tikosyn Capsules (Pfizer) – foreign tablet detected (2014)

Black Pepper Whole Organic (Natural Grocers) – unspecified issue (2014)

Buprenorphine Sublingual Tablets (Teva) – impurity problem (2014)

Buprenorphine Sublingual Tablets (Teva) – impurity issue (2014)

Sevoflurane Anesthetic (Piramal) – pH specification failure (2014)

Mercaptopurine Tablets (Boehringer) – expiration date error (2014)

Azathioprine Tablets (Boehringer) – expiration date error (2014)

Propofol Injectable Emulsion (Hospira) – glass defect (2014)

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

Fish Oil Softgel Capsules (Nutri-Force) – product mix-up (2014)

Lansoprazole Triple Therapy (Teva) – impurity concern (2014)

Psyllium Fiber Supplement (Konsyl) – strength labeling error (2014)

Glytone Acne Cleanser (Genesis) – viscosity issue (2014)

Hydroxyzine Oral Solution (Hi-Tech) – impurity problem (2014)

XZen Platinum (Nova Products) – Unapproved Drug Supplement (2014)

Xzone Capsules (Nova) – unapproved ingredients (2014)

Cilantro Herbal Supplement (Swanson) – manufacturing issue (2014)

African Black Ant Capsules (Nova) – unapproved ingredients (2014)

XZen Gold (Nova Products) – Unapproved Drug Supplement (2014)