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-Baroda Highway, Halol-389 350, Gujarat, India
Reported: February 1, 2017 Initiated: December 20, 2016 #D-0445-2017
Product Description
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-Baroda Highway, Halol-389 350, Gujarat, India
Reason for Recall
Failed Dissolution Specifications; 18 month stability time point
Details
- Recalling Firm
- Sun Pharmaceutical Industries, Inc.
- Units Affected
- a) 141,068 bottles b) 56,834 bottles c) 61,692 bottles
- Distribution
- Nationwide
- Location
- Cranbury, NJ
Frequently Asked Questions
What product was recalled? ▼
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-Baroda Highway, Halol-389 350, Gujarat, India. Recalled by Sun Pharmaceutical Industries, Inc.. Units affected: a) 141,068 bottles b) 56,834 bottles c) 61,692 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications; 18 month stability time point
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 1, 2017. Severity: Low. Recall number: D-0445-2017.
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