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 HCl Extended-Release Tablets (Metformin Hydrochloride)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx only, 500 count bottles, Manufactured by: Sun Pharmaceutical Inc. Ltd, Andheri (East) Mumbai-400 059, India, Distributed by: Caraco Pharmaceutical Laboratories, Ltd, Detroit, MI --- NDC 62756-142-02
Affected NDC
62756-0142-02
Compare with the code on your package — it is the most precise check available.
Drug: Metformin Category: Diabetes Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Metformin Hydrochloride NDC 62756-0142 |
500 mg/1 | Tablet, Extended Release Oral |
Sun Pharmaceutical Industries, Inc. | Rx |
- Recalling firm
- Caraco Pharmaceutical Laboratories, Ltd.
- NDC code
- 62756-142-02
- Origin
- MI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1089-2014 · 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 recalls by Caraco Pharmaceutical Laboratories, Ltd.
All 2014 recalls
Class II · Moderate risk
Cephalexin Capsules
CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.
Class II · Moderate risk
Cephalexin Capsules
CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.
Class II · Moderate risk
Venlafaxine Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications.
Class II · Moderate risk
Gemcitabine For Injection USP
Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance.
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