Recalls / Class II
Class IID-0330-2015
Product
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.
- Brand name
- Gabapentin
- Generic name
- Gabapentin
- Active ingredient
- Gabapentin
- Route
- Oral
- NDCs
- 16714-661, 16714-662, 16714-663
- FDA application
- ANDA078787
- Affected lot / code info
- Lot #: GESB14011-A, Exp 12/15
Why it was recalled
Failed Tablet/Capsule Specifications: Complaints of empty capsules received.
Recalling firm
- Firm
- Aurobindo Pharma USA Inc
- Manufacturer
- NorthStar Rx LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 6 Wheeling Road, N/A, Dayton, New Jersey 08810
Distribution
- Quantity
- 24,816 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-10-17
- FDA classified
- 2015-01-06
- Posted by FDA
- 2015-01-14
- Terminated
- 2016-05-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0330-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.