Status
Terminated
Drug Enforcement D-002-2013
Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.
Classification
Class III
Report Date
October 10, 2012
Termination Date
April 11, 2013
Product Information
- Product description
- 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.
- Product quantity
- 674 cartons
- Reason for recall
- Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Mckesson Packaging Services
- Address
-
7101 Weddington Rd NW, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-002-2013
- Event ID
- 63127
- Recall initiation date
- March 29, 2012
- Center classification date
- October 1, 2012
- Code info
- Lot #: 0075375, 0074584, Exp 08/12
- More code info
- —