Sumatriptan Succinate tablets recalled due to manufacturing temperature deviations
McKesson Medical-Surgical is recalling Sumatriptan Succinate 100 mg tablets due to temperature abuse during manufacturing that may affect quality. Consumers should consult their physician or pharmacist about whether they have an affected product.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving a manufacturing compliance deviation (temperature abuse) that may affect drug stability and efficacy. No illnesses or injuries have been reported. This meets the rubric criterion for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Sumatriptan Succinate 100 mg tablets (Rx only) distributed nationwide in the United States. The recall was initiated due to Good Manufacturing Practice (cGMP) deviations, specifically temperature abuse during the manufacturing process.
Temperature abuse during manufacturing may have affected the quality and stability of the affected tablets. The manufacturer was unable to identify the specific lot numbers at the distribution points, so all potentially affected product should be checked.
The recalled tablets were distributed nationwide. Consumers who possess the affected product should discontinue use and contact their healthcare provider or pharmacist for guidance on obtaining replacement medication.
The recalled product
- Product
- SUMATRIPTAN SUCCINATE (SUMATRIPTAN SUCCINATE)
- Brand
- SUMATRIPTAN SUCCINATE
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Prescription Medication
- Hazard
- temperature-abuse
- manufacturing-defect
- stability-compromise
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
UPCs (2)
- 0362756521889
- 0362756522886
Distribution
Distributed nationwide across the United States.
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