US Drug Recall Register
Class III · Low risk Terminated Initiated Aug 21, 2013 (13 years ago)

buPROPion Hydrochloride Extended-Release Tablets

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Failed Dissolution Specifications: This recall is an extension of the recall initiated on 07/31/2013 for Bupropion HCl Extended-Release Tablets (XL) 300 mg, because another lot was shown to have similar failing results for dissolution at the 8-hour timepoint.

What was recalled

buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic, LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217, NDC 67767-142-30, UPC 3 67767-142-30 6.

Recalling firm
Actavis South Atlantic LLC
NDC code
67767-142-30
Origin
FL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-917-2013

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Chloride recalls

See all
Class II · Moderate risk Ongoing

Clindamycin Palmitate Hydrochloride for Oral Solution

Reason Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.

Heritage Pharmaceuticals Inc NDC 23155-603-51 D-0768-2026
Class II · Moderate risk Ongoing

Dicyclomine Hydrochloride Capsules

Reason shortfill; reports of empty capsules.

Aurobindo Pharma USA Inc NDC 59651-719-99 D-0733-2026
Class II · Moderate risk Ongoing

Naropin

Reason Presence of Particulate Matter: Hair was found in products

Fresenius Kabi USA, LLC D-0727-2026
Class II · Moderate risk Ongoing

Rohto Cooling Eye Drops Cool Relief

Reason Lack of Assurance of Sterility

Rohto-Mentholatum (Vietnam) Co., Ltd. NDC 10742-8141-1 D-0722-2026
Class II · Moderate risk Ongoing

Rohto Cooling Eye Drops Optic Glow

Reason Lack of Assurance of Sterility

Rohto-Mentholatum (Vietnam) Co., Ltd. NDC 10742-8160-1 D-0718-2026