buPROPion Hydrochloride Extended-Release Tablet recall
buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 200 mg, 60-count bottle, Rx only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 47335-738-86
Why was buPROPion Hydrochloride Extended-Release Tablet 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: HAC2237A, exp. date 05/2023
- Product
- buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 200 mg, 60-count bottle, Rx only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 47335-738-86
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Quantity
- 744 bottles
- Distribution
- Nationwide in the USA
- Recall date
- May 18, 2022
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)