FDAFDA · Food and drugs·Recall number D-002-2013
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.
Published October 10, 2012 · Recall initiated: March 29, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- McKesson Packaging Services
- Distributor
- Nationwide
- Lot
- Lot #: 0075375, 0074584, Exp 08/12
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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