Class II Recall

SUN PHARMACEUTICAL INDUSTRIES INC

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.
Reason
Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
Classification
Class II
Status
Terminated
Lot
Lot number: DNC0432A, expiration 01/2023
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.