Class II · Moderate risk
amneal Metformin Hydrochloride Extended-release Tablets
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Diabetes Medication Recalls
Recalls of metformin and other drugs used to control blood sugar - metformin extended-release was recalled over the same nitrosamine impurity as valsartan.
161 recalls in this category, newest first.
Class II · Moderate risk
amneal Metformin Hydrochloride Extended-release Tablets
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
amneal Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels
Class III · Low risk
Pioglitazone and Metformin Hydrochloride Tablets
Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
Class II · Moderate risk
Pioglitazone Hydrochloride Tablets USP 15 mg
Superpotent
Class II · Moderate risk
GlipiZIDE Extended-release Tablets
Failed Dissolution Specifications: dissolution failure at time zero of the repackaged lot. Drug release results were slightly above specification at time zero.
Class II · Moderate risk
Glipizide XL
CGMP Deviations; rejected product was used to manufacture final bulk lot
Class II · Moderate risk
Actoplus met XR
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.
Class II · Moderate risk
Synjardy (empagliflozin and metformin hydrochloride)
Cross Contamination With Other Products:
Class II · Moderate risk
PIO&METFORMIN 15/1000 mg Tab 1
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class II · Moderate risk
Metformin Hydrochloride Extended Release Tablets 1000 mg
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class II · Moderate risk
Metformin Hydrochloride Extended Release Tablets 1000 mg
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class II · Moderate risk
Metformin Hydrochloride Extended Release Tablets
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class II · Moderate risk
Fortamet (metformin HCl)
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class II · Moderate risk
Admelog Solostar
Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.
Class II · Moderate risk
Metformin Hydrochloride Extended Release Tablets
Presence of foreign substance: One lot fo Metformin Hydrochloride Extended Release Tablets, USP, 500 mg (500 Count) contains foreign matter identified as a piece of rubber glove detected in one tablet.
Class III · Low risk
Riomet (metformin hydrochloride oral solution)
Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient literature.
Class III · Low risk
Metformin Hydrochloride Tablets
Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg
Class III · Low risk
Glipizide Extended-Release Tablets
Failed Moisture Limits: out of specification test results for water content obtained during stability testing.
Class II · Moderate risk
Riomet (metformin hydrochloride)
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Pioglitazone and Glimepiride Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Glipizide 2.5 mg ER Tablets
Failed Dissolution Specifications
Class II · Moderate risk
GlipiZIDE Extended-release tablets
Failed dissolution specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.
Class II · Moderate risk
Glipizide extended-release tablets
Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point.
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