The Recall Desk
LowFDA (Drugs)·D-002-2013·Announced 2012-10-10

McKesson Recalls bupropion Hydrochloride Extended-Release Tablets for Dissolution Failures

McKesson Packaging Services is recalling bupropion hydrochloride extended-release tablets because they failed USP dissolution test requirements.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor specification issues.

Plain-English summary

McKesson Packaging Services is recalling bupropion hydrochloride extended-release tablets (XL), 300 mg, NDC 63739-450-10. The recall involves 674 cartons of the medication, which are distributed nationwide. The specific lots affected are 0075375 and 0074584, with an expiration date of 08/12.

The recall was initiated because the tablets failed USP dissolution test requirements, specifically showing possible out-of-specification dissolution results at the 8-hour stability testing point. This indicates that the medication may not release the active ingredient at the required rate.

Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for a replacement or further instructions.

The recalled product

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, car
Manufacturer
McKesson Packaging Services
Category
Drug — Prescription Medication
Hazard
Affected units
674

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lot #: 0075375
  • 0074584
  • Exp 08/12

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by McKesson Packaging Services under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · McKesson Packaging Services

See all →

Same hazard · dissolution failure

See all →