Drug 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.
D-0330-2015
Product summary
- Event
- Event 69807
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24,816 bottles
- Official record key
drug-enforcement:D-0330-2015
Official wording
Reason: Failed Tablet/Capsule Specifications: Complaints of empty capsules received.
Code information: Lot #: GESB14011-A, Exp 12/15
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specifications: Complaints of empty capsules received.