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Montelukast Sodium Tablets (Glenmark) – Chemical Contamination (2013)

Chemical Contamination: The recall has been initiated based on multiple complaints received from pharmacists and consumers reporting that they detected an off-odor, described as moldy, musty or fishy in nature which has been identified as trace levels of Tribromoanisole (TBA) and Trichloroanisole (TCA).

Class IIILow

FDAFeb 13, 2013Nationwide• Glenmark Generics Inc., USA

ZARAH Tablets (Watson) – Tablet Breakage (2013)

Failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (dispenser) .

Class IIModerate

FDAFeb 13, 2013Nationwide

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Montelukast Sodium Tablets (Glenmark) – Chemical Contamination (2013)

ZARAH Tablets (Watson) – Tablet Breakage (2013)

Dextroamphetamine Tablets (Actavis) – Failed Dissolution (2013)

Sodium Chloride Irrigation (Hospira) – Sterility Risk (2013)

MAXILOSS Weight Advanced (OLAAX) – Unapproved Drug (2013)

Meprobamate 200mg Tablets (Watson) – Impurity Specification (2013)

Meprobamate 400mg Tablets (Watson) – Impurity Specification (2013)

Clonazepam Orally Disintegrating Tablets (Teva) – Content Uniformity (2013)

Ciprofloxacin Tablets (West-ward) – Foreign Substance (2013)

Salted Print Butter (Rose Valley) – Processing Violation (2013)

SourceCF Pediatric Drops (Aptalis Pharma) – Shelf Life Issue (2013)

Bupropion Extended Release Tablets (American Health) – Stability Issue (2013)

TEV-TROPIN Injection (Ferring) – Label Mix-up (2013)

Calcium Gluconate Injection (Fresenius) – Missing Label (2013)

Triaminic & Theraflu Syrups (Novartis) – Closure Failure (2013)

Vistide Injection (Gilead) – Particulate Matter Presence (2013)

Daytrana Patch (Noven) – Defective Delivery System (2013)

Suprax Cefixime (Lupin) – Color Specification Issue (2013)

AMBI 15DM/100GFN/5PEH (TG United) – Dosage Incorrect (2013)

Dallergy Chewable Tablets (TG United) – Incorrect Dosage (2013)