buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 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 NDC 47335-0738-86
Reported: February 1, 2017 Initiated: December 20, 2016 #D-0446-2017
Product Description
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 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 NDC 47335-0738-86
Reason for Recall
Failed Dissolution Specifications; 18 month stability time point
Details
- Recalling Firm
- Sun Pharmaceutical Industries, Inc.
- Units Affected
- 11,618 bottles
- Distribution
- Nationwide
- Location
- Cranbury, NJ
Frequently Asked Questions
What product was recalled? ▼
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 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 NDC 47335-0738-86. Recalled by Sun Pharmaceutical Industries, Inc.. Units affected: 11,618 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-0446-2017.
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