Drug product
Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-138-05; b) 1000-count bottles, NDC 62756-138-04, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India.
D-0311-2025
Product summary
- Event
- Event 96415
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 12,876 bottles
- Official record key
drug-enforcement:D-0311-2025
Official wording
Reason: Cross Contamination
Code information: Lot # a) HAD1458A, Exp. date 04/2025, HAD2718A, Exp. date 07/2025, b) HAD3432A, exp. date 08/2025
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Cross Contamination