Why it was recalled
Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.
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.
Lot numbers, UPCs & expiration codes
Lot #: 0075375, 0074584, Exp 08/12
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-002-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 29, 2012
- FDA report date
- Oct 10, 2012
- Quantity
- 674 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- McKesson Packaging Services
Original FDA data
Every field from FDA enforcement report D-002-2013, exactly as published.
Show all FDA fields
- City
- Concord
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 63127
- Address
- 7101 Weddington Rd NW
- Code information
- Lot #: 0075375, 0074584, Exp 08/12
- Postal code
- 28027-3412
- Report date
- Oct 10, 2012
- Product type
- Drugs
- Recall number
- D-002-2013
- Classification
- Class III
- Recalling firm
- McKesson Packaging Services
- Product quantity
- 674 cartons
- Termination date
- Apr 11, 2013
- Reason for recall
- Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 29, 2012
- Initial firm notification
- Letter
- Center classification date
- Oct 1, 2012