Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
metformin HCL ER 750 mg Rx only Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 tablets NDC: 43063-902-30; b) 60 tablets NDC: 43063-902-60
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been…
Reason CGMP Deviations
Reason Presence of Foreign Tablets/Capsules.
Reason Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.
Reason CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
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