Lack of Assurance of Sterility: Sterility of product is not assured.
Prescription Drugs
π Drugs β’ 12,141 recalls
Lack of Assurance of Sterility: Sterility of product is not assured.
Lack of Assurance of Sterility: Sterility of product is not assured.
Failed stability specifications:This recall has been initiated due to out of specification results for viscosity.
Labeling: Incorrect or Missing Package Insert; Product is being recalled because the birth control packs were distributed with out-dated package inserts.
Subpotent drug
Lamivudine and Zidovudine Tablets USP 150mg/300mg 30 Unit Dose Blisters, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton of 30: NDC 68084-0416-21, Individual dose: NDC 68084-0416-11
American Health Packaging
Failed dissolution specifications
NEXIUMΒΏ (esomeprazole magnesium), Delayed-Release capsules, 20 mg, 30-count bottle, Rx only, Manufactured for AstraZeneca LLC, Wilmington, Distributed by AstraZeneca, AB, Sodertalje, Sweden. NDC 00186-5020-31.
AstraZeneca Pharmaceuticals
Presence of Foreign Tablets/Capsules: Confimed customer compliant by a retail pharmacist that an unopened bottle labeled as NEXIUMΒΏ capsules contained 60 SEROQUELΒΏ XR tablets.
Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Subpotent drug
Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
CGMP Deviations: Failure of the manufacturer, Wockhardt Ltd, to adequately investigate customer complaints.
Amlodipine besylate and Atorvastatin calcium tablets, 10mg/40mg, 90-count bottle, Rx Only Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India, NDC 43598-315-90
Dr. Reddy's Laboratories
Subpotent drug
Subpotent drug
Divalproex Sodium Extended-Release Tablets, USP, 500 mg, 100 count bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited Bachupally 500 090 India --- NDC 55111-534-01
Dr. Reddy's Laboratories
Failed Dissolution Specifications; exceeded specification at the 9 hour time point
Failed Dissolution Specifications; exceeded specification at the 9 hour time point
Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
Glutathione INHALATION (PF), solution, 100mg/mL, 4 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT.
Montana Compounding Pharmacy
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Bimix (PHENT;PAP) (N), solution, (10/300) 1 - 30 mg/mL, injectable, 5ml vial, Rx only, compounded by Montana Compounding Pharmacy in Missoula, MT.
Montana Compounding Pharmacy
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection