buPROPion Hydrochloride Extended Release Tablets USP (SR) 150 mg Rx Only 60 tablets Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol 389-350 Gujarat India ---- NDC 47335-737-86
Reported: July 27, 2016 Initiated: June 27, 2016 #D-1446-2016
Product Description
buPROPion Hydrochloride Extended Release Tablets USP (SR) 150 mg Rx Only 60 tablets Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol 389-350 Gujarat India ---- NDC 47335-737-86
Reason for Recall
Failed Dissolution Specifications
Details
- Recalling Firm
- Sun Pharmaceutical Industries, Inc.
- Units Affected
- 16,085 bottles
- Distribution
- Nationwide
- Location
- Cranbury, NJ
Frequently Asked Questions
What product was recalled? ▼
buPROPion Hydrochloride Extended Release Tablets USP (SR) 150 mg Rx Only 60 tablets Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol 389-350 Gujarat India ---- NDC 47335-737-86. Recalled by Sun Pharmaceutical Industries, Inc.. Units affected: 16,085 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 27, 2016. Severity: Low. Recall number: D-1446-2016.
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