Sun Pharmaceutical Industries, Inc.: buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (NDC 47335-737-86), b) 100 (NDC 47335-737-88) and c) 500 (NDC 47335-737-13) count bottles

Is my product affected?

buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (NDC 47335-737-86), b) 100 (NDC 47335-737-88) and c) 500 (NDC 47335-737-13) count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-

• Brand BUPROPION HYDROCHLORIDE

Check against the official notice below — it lists the full affected range.

What happened

Sun Pharmaceutical Industries, Inc. is recalling bupropion hydrochloride extended-release tablets, USP (SR), 150 mg in three bottle sizes: 60-count, 100-count, and 500-count bottles distributed nationwide. The recall affects a total of 259,594 bottles across all sizes due to failed dissolution specifications at the 18-month stability time point. Multiple lot codes with expiration dates ranging from January 2017 through October 2017 are included in the recall.

The affected lot codes are identified by their specific lot numbers and expiration dates for each bottle size. The record does not specify a remedy for consumers who have purchased these products.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Failed Dissolution Specifications; 18 month stability time point

Details from the source

Reason for recall: Failed Dissolution Specifications; 18 month stability time point Distribution: Nationwide Quantity: a) 141,068 bottles b) 56,834 bottles c) 61,692 bottles Lot/code info: a) 60 count JKP1184A , exp 2/17; JKP1576A, JKP2517A, JKP2527A, exp 04/17; JKP2768A exp 06/17; KP3895A, JKP4051A, exp 08/17; JKP4052A, JKP4605A exp 09/17 b) 100 count JKP0702A exp 01/17; JKP1186A exp 02/17; JKP2766A, exp 05/17; JKP3368A, JKP3369A exp 06/17; JKP3419A, JKP3420A exp 07/17; JKP4056A, JKP4603A, exp 09/17 c) 500 count JKP0093A, JKP0094A, JKP0703A, JKP0704A, exp 01/17; JKP1182A, JKP1183A, JKP1185A, exp 02/17; JKP1187A, JKP1188A, JKP1577A, JKP1578A, JKP2528A, exp 04/17; JKP2764A, JKP2765A, JKP2767A, exp 05/17; JKP3370A, JKP3371A, exp 06/17; JKP3372A, JKP3417A, JKP3418A, JKP3421A, JKP3889A, exp 07/17; JKP3892A, JKP3893A, JKP3894A, exp 08/17; JKP4053A, JKP4054A, JKP4055A, JKP4057A, JKP4600A, JKP4601A, JKP4602A, exp 09/17; JKP4742A, JKP4743A, exp 10/17

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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