SUN PHARMACEUTICAL INDUSTRIES medroxyPROGESTERone Acetate Injectable Suspension, USP, 25 x 1 recall — FDA D-1147-2022
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
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
Lack of assurance of sterility
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Lack of assurance of sterility
Marketed Without An Unapproved NDA/ANDA: Product lot found to be tainted with undeclared diclofenac, an FDA approved nonsteroidal anti-inflammatory drug (NSAID) for the treatment of pain…
Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Lack of assurance of sterility
cGMP deviations
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Lack of Assurance of Sterility
Failed Impurities/Degradation Specifications.
cGMP deviations: Temperature abuse
Failed Impurities/Degradation Specifications.
cGMP deviations: Temperature abuse
Failed Impurities/Degradation Specifications.
Failed Impurities/Degradation Specifications.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
A drug recall record can include the reason for recall, firm, status, distribution pattern, quantity and FDA classification. This site does not provide medical advice; it organizes public recall information and links users back to official sources.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.