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 .
Gabapentin Capsules
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Tablet/Capsule Specifications: Complaints of empty capsules received.
What was recalled
Gabapentin Capsules, USP 300 mg, 100-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141; Manufactured by: Aurobindo Pharma Limited, Unit-VII (SEZ), Mahaboob Nagar (Dt), AP-509302, INDIA, NDC 16714-662-01, UPC 3 16714-662-01 5.
- Recalling firm
- Aurobindo Pharma USA Inc
- NDC code
- 16714-662-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0330-2015
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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