PlainRecordsFDA · Drug recall
buPROPion Hydrochloride Extended-Release Tablet… and 1 more product
- Date
- May 18, 2022
- Risk class
- Class III (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences)
- Status
- Terminated
- Filed by
- Sun Pharmaceutical Industries Inc
- Reason
- 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.
- Distribution pattern
- Nationwide in the USA
2 products in this recall
buPROPion Hydrochloride Extended-Release Tablet…
- Product
- buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 150 mg packaged in a) 60-count bottle (47335-737-86), b)100-count bottle (47335-737-88), c)500-count bottle (47335-737-13), 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
- Quantity
- 9804 bottles
- Codes and lots
- Lot #: a) JKX5126A, JKX5127A, JKX5128A, Exp 10/2022; b) JKX5126B , JKX5128B, Exp 10/2022; c)JKX5126C, JKX5127C, JKX5128C, Exp 10/2022;
- Recall started
- April 29, 2022
- Recall number
- D-0857-2022
buPROPion Hydrochloride Extended-Release Tablet…
- 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
- Quantity
- 744 bottles
- Codes and lots
- Lot #: HAC2237A, exp. date 05/2023
- Recall started
- April 29, 2022
- Recall number
- D-0858-2022
What should I do? Medicine recall: what to do
Source: FDA · Drug enforcement reports, recall numbers D-0857-2022, D-0858-2022. The agency record governs; check it and the company before acting.