Recalls / Class III
Class IIID-002-2013
Product
buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, UD 100 Tablets (10 x 10) per carton, Rx only, Mfg By: CMIC-VPS Corporation, Cranbury, New Jersey 08512; blister barcode N (01)003 63739 450 10 3, Dist By: McKesson Packaging, Concord, NC 28027; NDC 63739-450-10, carton barcode 6373945010.
- Affected lot / code info
- Lot #: 0075375, 0074584, Exp 08/12
Why it was recalled
Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.
Recalling firm
- Firm
- McKesson Packaging Services
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7101 Weddington Rd NW, N/A, Concord, North Carolina 28027-3412
Distribution
- Quantity
- 674 cartons
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-03-29
- FDA classified
- 2012-10-01
- Posted by FDA
- 2012-10-10
- Terminated
- 2013-04-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-002-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.