Class I - Dangerous
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions
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Prescription Drugs
💊 Drugs • 12,141 recalls
Class I - Dangerous
CGMP Deviations: Failure to properly investigate failed microbial testing.
Class I - Dangerous
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Class I - Dangerous
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Class I - Dangerous
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Class I - Dangerous
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
Class I - Dangerous
Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
Class I - Dangerous
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-19
Lupin Pharmaceuticals
Class I - Dangerous
Failed Stability Specification
Class I - Dangerous
Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
Class I - Dangerous
Subpotent Drug
Esomeprazole Magnesium Delayed-Release Capsules, USP 20 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 42292-009-16
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
Failed Dissolution Specifications: low out of specification results for dissolution.
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