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High bacterial growth within products
Presence of Particulate Matter: A complaint was received for the presence of a single strand of hair in one vial.
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL).
Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,
Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
The product label claim for copper is 0.5mg, but third-party lab results revealed product contains higher levels of copper.
Lack of Assurance of Sterility
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually contained 100 tablets of 20 mg strength of the drug product.
Best Nutritionals LLC 120 Centennial Ave, Piscataway NJ 08854, is initiating a recall of Fenugreek 610 mg , 360 Capsules ,in White Plastic HDPE bottles because the product has the potential to be contaminated with Salmonella.