Severity
Low
LowClass IIITerminated
FDA Drug recall · Reported October 10, 2012
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.
Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
McKesson Packaging Services recalled buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, UD 100 Tablets (10 x 10) p… - a low-severity action.
buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, UD 100 Tablets (10 x 10) p… was recalled by McKesson Packaging Services in October 10, 2012. Reason: Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour sta…. Check the official notice for the remedy. Verify recall #D-002-2013 with the FDA Drug before acting.
The recall
McKesson Packaging Services issued this low-severity FDA Drug recall-Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour sta….
- Low
- severity level
- Class III
- classification
- October 10, 2012
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-002-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-002-2013) was formally reported on October 10, 2012, with the manufacturer initiating the action on March 29, 2012. It is classified under Low severity (Class III), with a current status of Terminated. McKesson Packaging Services is listed as the recalling firm, operating out of Concord, NC. Federal records list the affected scope as 674 cartons.
The documented reason for this recall is: Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point. Distribution data in the federal record shows the product reached: Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
674 cartons
Related Recalls
6
5 from same agency
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.
Reason for recall
Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-002-2013 |
| Date reported | October 10, 2012 |
| Date initiated | March 29, 2012 |
| Recalling firm | McKesson Packaging Services |
| Firm location | Concord, NC |
| Affected scope | 674 cartons |
| Distribution | Nationwide |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-002-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by McKesson Packaging Services. Units affected: 674 cartons.
Why was this product recalled? ▼
Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 10, 2012. Severity: Low. Recall number: D-002-2013.
Where was the recalled product distributed? ▼
Distribution: Nationwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-002-2013) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported October 10, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.