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.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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…
- 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.
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