CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
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Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC…
Presence of Particulate Matter; identified as stainless steel
Read MoreDabigatran Etexilate Capsules, 75 mg, 60-count (6×10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by:…
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities…
Read MoreDabigatran Etexilate Capsules, 75 mg, 30-count (3×10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed…
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities…
Read MoreAzelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ 07407, NDC…
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
Read MoreMycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV, 26505…
Presence of precipitate
Read MoreDorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL – bottle, Rx only, Manufactured by: Micro Labs Limited, India, Manufactured for: Micro Labs…
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Read MoreDabigatran Etexilate Capsules, 150 mg, 60-count (6×10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed…
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities…
Read MoreRohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard…
Lack of Assurance of Sterility
Read MoreLevothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by:…
Subpotent Drug
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