Class II · Moderate risk
Synjardy XR Tablets
CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.
Metformin Hydrochloride USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: The Active Pharmaceutical Ingredient was not manufactured according to current good manufacturing practices.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Metformin Hydrochloride USP, Active Pharmaceutical Ingredient for manufacturing, processing or re-packing use only, 25 kg drum, Rx only, Manufactured by: Smruthi Organics Limited, Plot No.: A-27 M.I.D.C., Chincholi, Taq.: Mohol, Solapur-413 255. Maharashtra, India; NDC No. 10828-002-06, Cas No: 1115-70-4
Affected NDC
10828-0002-06
Compare with the code on your package — it is the most precise check available.
Drug: Metformin Category: Diabetes Medication
- Recalling firm
- Betachem, Inc.
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-406-2014 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Metformin recalls
See all
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets 1000mg
CGMP Deviations
Class II · Moderate risk
Metformin Hydrochloride Extended- Release 500mg
Presence of Foreign Tablets/Capsules.
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
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.
Class II · Moderate risk
Metformin hydrochloride Extended-Release Tablets
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Other cgmp deviation recalls from 2013
All cgmp deviation recalls
Class II · Moderate risk
Lamotrigine Tablets
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices
Class II · Moderate risk
Ciprofloxacin Tablets
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices
Class II · Moderate risk
Amlodipine Besylate Tablets
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class II · Moderate risk
Amlodipine Besylate Tablets
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
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