Class III · Low risk
Trokendi XR
Failed dissolution specifications.
TOPIRAMATE Tablets 200 mg
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.
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
TOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only. Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ USA 08534. NDC 68382-141-14.
Affected NDC
68382-0141-14
Compare with the code on your package — it is the most precise check available.
Drug: Topiramate
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 |
|---|---|---|---|---|
| topiramate NDC 68382-0141 |
200 mg/1 | Tablet, Film Coated Oral |
Zydus Pharmaceuticals USA Inc. | Rx |
- Recalling firm
- Zydus Pharmaceuticals USA Inc
- NDC code
- 68382-141-14
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0015-2015 · 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 Topiramate recalls
See all
Class III · Low risk
Trokendi XR
Failed Dissolution Specifications
Class III · Low risk
Eprontia (topiramate)
Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
Class III · Low risk
Topiramate Tablets
Discoloration
Class II · Moderate risk
Trokendi XR
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Other recalls by Zydus Pharmaceuticals USA Inc
All 2014 recalls
Class II · Moderate risk
Mirabegron Extended-Release Tablets
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Class II · Moderate risk
Erythromycin Tablets
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Class II · Moderate risk
Erythromycin Tablets
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Class II · Moderate risk
Icosapent Ethyl Capsules
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
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