Class I - Dangerous
Failed Dissolution Specifications: low out of specification results for dissolution.
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Class I - Dangerous
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
Class I - Dangerous
Subpotent Drug
Class I - Dangerous
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
Class I - Dangerous
Subpotent Drug
Class I - Dangerous
Defective container: loose crimp defect, potential loss of container integrity.
Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carton), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC 42292-010-16
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Class I - Dangerous
Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
Class I - Dangerous
Subpotent Drug
Class I - Dangerous
Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.
Class I - Dangerous
Subpotent Drug
Class I - Dangerous
Failed Dissolution Specifications: low out-of-specification dissolution test results observed.
Class I - Dangerous
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class I - Dangerous
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class I - Dangerous
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class I - Dangerous
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Class I - Dangerous
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Vancomycin HCl 1.5 g in 0.9% Sodium Chloride, 500 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0924-44
SCA Pharmaceuticals
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Norepinephrine 8mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-078-40
SCA Pharmaceuticals
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits