Prescription and over-the-counter medications
Bryant Ranch Prepack, Inc.
Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets.
Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
Breckenridge Pharmaceutical
Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing.
cGMP deviations: The quantity of active ingredient used for the product lot was inadvertently taken from an ingredient lot from an alternate supplier before that specific lot was formally qualified for use by the manufacturing site.
Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolactone 50 mg tablets.
Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rather than the correct refrigerated (2 - 8 ¿C) storage conditions
Labeling: Incorrect or Missing Lot and/or Exp Date
Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP
Dr. Reddy's Laboratories
Failed Dissolution Specifications: Out-of-specification results observed for dissolution during stability testing.
Jubilant Cadista Pharmaceuticals
Labeling: Illegible label: Customer complaint received of mis-alignment print of the printed dosing instructions on the blister card.
Dr. Reddy's Laboratories
Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities
Aurobindo Pharma USA
Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg.
Defective Delivery System: Out of specification for mechanical peel.
SUN PHARMACEUTICAL INDUSTRIES
Subpotent
Teva Pharmaceuticals USA
Chemical contamination; Unknown brown residue adhering to the inside of one vial.
Defective Delivery System: Out of specification for mechanical peel.
Defective Delivery System: Out of specification for mechanical peel.
Defective Delivery System: Out of specification for mechanical peel.
Teva Pharmaceuticals USA
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.