Class II
Terminated
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.
- Recall Initiated
- October 22, 2021
- Posted
- January 12, 2022
- Recall Number
- D-0361-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 696 Bottles
- Firm Location
- Princeton, NJ, United States
Reason for Recall
Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
Distribution
Nationwide in the USA
Lot / Code Info
Lot number: DNC0432A, expiration 01/2023
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