D-0361-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 12, 2022
- Initiation Date
- October 22, 2021
- Termination Date
- April 6, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 696 Bottles
Product Description
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.
Reason for Recall
Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
Distribution Pattern
Nationwide in the USA
Code Information
Lot number: DNC0432A, expiration 01/2023