Drug product
Pregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15 Dadra-396 191, (U.T. of D & NH), India, NDC 47335-687-88.
D-0361-2022
Product summary
- Event
- Event 88927
- Status
- Terminated
- Classification
- Class II
- Quantity
- 696 Bottles
- Official record key
drug-enforcement:D-0361-2022
Official wording
Reason: Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
Code information: Lot number: DNC0432A, expiration 01/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of Specification