Recalls of metformin and other drugs used to control blood sugar - metformin extended-release was recalled over the same nitrosamine impurity as valsartan.
160 recalls in this category, newest first.
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels
Reason Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
Reason Superpotent
Reason Failed Dissolution Specifications: dissolution failure at time zero of the repackaged lot. Drug release results were slightly above specification at…
Reason CGMP Deviations; rejected product was used to manufacture final bulk lot
Reason Defective Delivery System: tablets may be missing, in whole or in part, the laser drilled holes on the metformin core of the Actoplus met XR tablets.
Reason Cross Contamination With Other Products:
Reason Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Reason Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Reason Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Reason Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Reason Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Reason Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.
Reason Presence of foreign substance: One lot fo Metformin Hydrochloride Extended Release Tablets, USP, 500 mg (500 Count) contains foreign matter…
Reason Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient…
Reason Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg
Reason Failed Moisture Limits: out of specification test results for water content obtained during stability testing.
Reason Microbial Contamination of Non-Sterile Products
Reason Failed Dissolution Specifications
Reason Failed Dissolution Specifications
Reason Failed dissolution specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.
Reason Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point.
Reason Presence of Foreign Tablets/Capsules; bottles of Glipizide 5 mg tablets may contain Glipizide 10 mg tablets
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