Class III · Low risk
Cisatracurium Besylate Injection USP
Subpotent product:out of specification assay results observed during long term stability testing.
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Class III · Low risk
Cisatracurium Besylate Injection USP
Subpotent product:out of specification assay results observed during long term stability testing.
Class III · Low risk
Cisatracurium Besylate Injection USP
Subpotent product:out of specification assay results observed during long term stability testing.
Class II · Moderate risk
Baclofen Tablets USP
Presence of Foreign Tablets/Capsules
Class III · Low risk
Morphine Sulfate Oral Solution 100 mg / 5 mL
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Class III · Low risk
Bisoprolol Fumarate and Hydrochlorothiazide Tablets
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Class II · Moderate risk
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac…
Incorrect Product Formulation
Class III · Low risk
Nebivolol Tablets
Cross Contamination with Other Products
Class II · Moderate risk
Ondansetron ODT Tablets
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Class II · Moderate risk
Cinacalcet Hydrochloride Tablets
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II · Moderate risk
Cinacalcet Hydrochloride Tablets
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II · Moderate risk
Cinacalcet Hydrochloride Tablets
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II · Moderate risk
Ganirelix Acetate Injection
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Class II · Moderate risk
Walgreens Saline Nasal Spray WITH XYLITOL
Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis
Class III · Low risk
Varenicline Tablets
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Class III · Low risk
Carton label: Testosterone Gel 1%
Defective Container - A defect in the side-seal which allows leakage of product.
Class I · High risk
Famotidine Injection
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Class II · Moderate risk
Sertraline Hydrochloride Tablets USP
Defective container - seal not adhering to bottles
Class II · Moderate risk
OraVerse
Defective container: cracked/broken cartridges
Class II · Moderate risk
Cook-Walte
Defective container: cracked/broken cartridges
Class II · Moderate risk
Benco dental Graham CHEMICAL CO.
Defective container: cracked/broken cartridges
Class II · Moderate risk
darby dental supply
Defective container: cracked/broken cartridges
Class II · Moderate risk
3% Polocaine DENTAL
Defective container: cracked/broken cartridges