POLOCAINE 3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) recall — FDA D-0230-2026
Defective container: cracked/broken cartridges
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.
754 detailed records are currently available in this category.
Defective container: cracked/broken cartridges
Subpotent product:out of specification assay results observed during long term stability testing.
Defective container: cracked/broken cartridges
Subpotent product:out of specification assay results observed during long term stability testing.
Defective container: cracked/broken cartridges
Failed stability specifications: Out of specification for hardness test
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Failed stability specifications: Out of specification for hardness test
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Defective Container - A defect in the side-seal which allows leakage of product.
Failed Stability Specifications: Observed OOS results: eg results for colour index
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
CGMP Deviations
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
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