Class II · Moderate risk Ongoing
Gabapentin Capsules
Reason Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Glenmark Gabapentin Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Chemical Contamination: Gabapentin Sodium tablets is recalled due to complaints related to an off - odor described as moldy, musty or fishy in nature.
What was recalled
Glenmark Gabapentin Tablets, a) 600mg, 500- count bottle (NDC 68462-126-05), b) 800 mg, 500- count bottle (NDC 68462-127-05), 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
- 68462-126-05
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-329-2013
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 Gabapentin recalls
See all
Class II · Moderate risk Ongoing
Gabapentin Capsules
Reason Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Class II · Moderate risk Ongoing
Gabapentin Capsules
Reason Defective container; blister packaging inadequately sealed.
Class II · Moderate risk Ongoing
Gabapentin Capsules
Reason Defective container; blister packaging inadequately sealed.
Class II · Moderate risk Ongoing
Gabapentin Tablets 600mg
Reason CGMP Deviations
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