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Class III · Lower riskRecall completed

buPROPion Hydrochloride Extended-Release Tablets (XL)

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot #: 0075375, 0074584, Exp 08/12
Where it was soldNationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Distributed by / forMcKesson Packaging Services
NDC63739-450-10
Show the full FDA record
Full product labelbuPROPion 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.
Recalling firmMcKesson Packaging Services
DistributionNationwide
Quantity674 cartons
Recall initiated2012-03-29
Report date2012-10-10
Recall completed2013-04-11
Recall numberD-002-2013
ClassificationClass III
FDA statusTerminated
Origin on fileConcord NC United States

Related

Bupropion recallsRecent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.