Reported May 18, 2022 · Terminated
buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 200 mg, 60-count bottle, Rx only 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 Tablet, USP (SR), 200 mg, 60-count bottle
- Rx only 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 #: HAC2237Aexp. date 05/2023
- Amount recalled
- 744 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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