FDAFDA · Food and drugs·Recall number D-0361-2022
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.
Published January 12, 2022 · Recall initiated: October 22, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- PREGABALIN
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Distributor
- Nationwide in the USA
- UPC
- 0347335692884
- Lot
- Lot number: DNC0432A, expiration 01/2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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