Olympia Compounding Pharmacy dba Olympia Formula F1 Papaverine 1.8 mg/mL Phentolamine 0.2 recall — FDA D-0927-2022
Lack of assurance of sterility.
Browse U.S. drug recall enforcement reports from the FDA in a structured, searchable format. Review the recalled product, reason, firm, status, dates, distribution information and FDA classification when available.
10,685 detailed records are currently available in this category.
Lack of assurance of sterility.
Lack of assurance of sterility.
Lack of assurance of sterility.
Lack of assurance of sterility.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Lack of assurance of sterility.
Lack of assurance of sterility.
Lack of assurance of sterility.
Lack of assurance of sterility.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.
Subpotent drug: Low OOS for menthol content at the three month room temperature.
Microbial Contamination of Non-Sterile Products
Microbial Contamination of Non-Sterile Products
CGMP Deviations: Failure to properly investigate failed microbial testing.
CGMP Deviations: Failure to properly investigate failed microbial testing.
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
CGMP Deviations: Failure to properly investigate failed microbial testing.
Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits.
Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
Failed Dissolution Specifications: low out of specification results for dissolution.
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…
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…
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