Drug recall D-0361-2022
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 for recall
Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
Lots and codes
Lot number: DNC0432A, expiration 01/2023
Recall details
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ
- Quantity
- 696 Bottles
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- October 22, 2021
- Terminated
- April 6, 2023
Related products
- Pregabalin – drug information
- NDC 47335-686 Pregabalin · Pregabalin 25 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 47335-691 Pregabalin · Pregabalin 200 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 47335-689 Pregabalin · Pregabalin 100 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 47335-693 Pregabalin · Pregabalin 300 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 47335-687 Pregabalin · Pregabalin 50 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 47335-692 Pregabalin · Pregabalin 225 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 47335-688 Pregabalin · Pregabalin 75 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 47335-690 Pregabalin · Pregabalin 150 mg/1 · Sun Pharmaceutical Industries, Inc.