SUN PHARMACEUTICAL INDUSTRIES INC recalls Pregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ
Recalled January 12, 2022 · FDA recall D-0361-2022 · SUN PHARMACEUTICAL INDUSTRIES
Hazard
Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient. · FDA Class II
Units
696 Bottles
Sold at
Nationwide in the USA
Description
Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
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.
Manufacturer(s)
SUN PHARMACEUTICAL INDUSTRIES INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →