Class III · Low risk Ongoing
Trokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions…
Reason Failed Dissolution Specifications
Glenmark Topiramate Tablets, 200 mg, 60-count bottle, (NDC 68462-110-60), Rx only…
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off - odor. described as moldy, musty or fishy in nature.
What was recalled
Glenmark Topiramate Tablets, 200 mg, 60-count bottle, (NDC 68462-110-60), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India Manufactured for : Glenmark Generics USA Mahwah, NJ 07430
- Recalling firm
- Glenmark Generics Inc., USA
- NDC code
- 68462-110-60
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-331-2013
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.
Other Topiramate recalls
See all
Class III · Low risk Terminated
Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn, MA…
Reason Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine…
Class III · Low risk Terminated
Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Laboratories LTD, Ind. Area. Meerut Road…
Reason Discoloration
Class II · Moderate risk Terminated
Trokendi XR (topiramate) extended-release capsules 100 mg 30 Capsules Rx only, Manufactured by: Catalent Pharma Solutions…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Topiramate 25mg Tabs White/round tablets, 10-count bags, Distributed by: Calvin Scott & Co., Inc. Alb., MN 87123, Mfg: Sun…
Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
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