buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceutical Industries Limited, Gujrat, India, NDC 47335-737-86
Reported: May 31, 2023 Initiated: May 9, 2023 #D-0761-2023
Product Description
buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceutical Industries Limited, Gujrat, India, NDC 47335-737-86
Reason for Recall
Failed Dissolution Specifications; during stability testing
Details
- Recalling Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Units Affected
- 5,344 Bottles
- Distribution
- Nationwide in the U.S.A
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceutical Industries Limited, Gujrat, India, NDC 47335-737-86. Recalled by SUN PHARMACEUTICAL INDUSTRIES INC. Units affected: 5,344 Bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications; during stability testing
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 31, 2023. Severity: Moderate. Recall number: D-0761-2023.
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