The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-001-2013·Announced 2012-10-10

McKesson Recalls bupropion Hydrochloride Extended-Release Tablets Due to Dissolution Failure

McKesson Packaging Services is recalling 187 cartons of bupropion Hydrochloride Extended-Release Tablets, 150 mg, 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The specific hazard is a quality control failure (dissolution) rather than a direct physical injury risk.

Plain-English summary

McKesson Packaging Services is recalling 187 cartons of bupropion Hydrochloride Extended-Release Tablets (XL), 150 mg. The product is identified by NDC 63739-449-10, Lot # 0074583, and an expiration date of 03/12. The tablets were manufactured by CMIC-VPS Corporation and distributed nationwide.

The recall was initiated because the product failed USP Dissolution Test Requirements, specifically showing possible out-of-specification dissolution results at the 8-hour stability testing point. This indicates the tablets may not release the medication as intended.

Consumers should stop using the recalled product and return it to their pharmacy or contact McKesson Packaging Services for a replacement or refund. Healthcare providers should verify their inventory against the specific lot and expiration date listed above.

The recalled product

Product
buPROPion Hydrochloride Extended-Release Tablets (XL), 150 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 449 10 7, Dist By: McKesson Packaging, Concord, NC 28027; NDC 63739-449-10…
Manufacturer
McKesson Packaging Services
Category
Drug — Prescription Medication
Hazard
Affected units
187

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 (2)

  • Lot #: 0074583
  • Exp. Date 03/12

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 →

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