Reported Dec 13, 2023 · Terminated
buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets bottle, Distributed by: Sun…
Sun Pharmaceutical Industries Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SUN PHARMACEUTICAL INDUSTRIES INC · 2 Independence Way · Princeton, NJ · 08540-6620
Is this the product you have?
- buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets bottle
- Distributed bySun Pharmaceutical Industries, Inc., Cranbury, NJ 08512
- Manufactured bySun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-738-86
- Lot codes and dates
Lot HAD0630Aexp 1/2024
- Amount recalled
- 2016 Bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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