CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Prescription Drugs
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CGMP Deviations: Intermittent exposure to temperature excursion during storage.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Cetirizine Hydrochloride Tablets, 10 mg, 300 Count; NDC/UPC 345802919878; OTC; TABLETS
Cardinal Health
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
VIMPAT (lacosamide) Tablets, 200mg, 60-count bottle, Rx Only, Manufactured for: UCB, Inc. Smyrna, GA 30080, NDC 0131-2480-35
Cardinal Health
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Subpotent Drug
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
COREG CR (carvedilol phosphate) Extended Release Capsules, 80 mg, 30-count bottle, Rx Only,/UPC 57664066683
Cardinal Health
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC, packaged in a case containing 2 x 6 Liter bags, Rx only, NDC 49230-206-60, Fresenius Medical Care North America, Waltham, MA 02451
Fresenius Medical Care, North America
Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box.
Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 00703-7121-03
Teva Pharmaceuticals USA
Lack of Assurance of Sterility
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and tadalafil.
Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794-016-10.
SigmaPharm Laboratories
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Subpotent Drug