FDA Issues Class II Recall of Sumatriptan Injection Due to Temperature Exposure
McKesson Medical-Surgical is recalling Sumatriptan Injection, USP, 6mg/0.5mL nationwide due to temperature abuse during distribution that may have affected medication stability and potency.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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 with no reported illnesses or injuries. Temperature abuse of an injectable medication presents potential risk-of-harm through stability degradation and loss of potency, but no adverse health consequences have been documented in the source.
Plain-English summary
Sumatriptan Injection, USP, 6mg/0.5mL packaged in boxes of 5 single-dose vials is being recalled. The product is manufactured by Auromedics Pharma LLC and distributed by McKesson Medical-Surgical Inc.
The recall was issued because of cGMP deviations involving temperature abuse. Temperature exposure during distribution may have affected the medication's stability and potency.
The recall affects Sumatriptan Injection distributed nationwide. Patients and healthcare facilities that received this product should determine whether their supply is affected by reviewing their distribution records.
If you have questions or concerns about your supply, contact McKesson Medical-Surgical Inc. or your healthcare provider. Patients should not discontinue use without consulting their healthcare provider.
The recalled product
- Product
- Sumatriptan Injection, USP, 6mg/0.5 mL, packaged in a box of 5 x 0.5 mL single-dose vials, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0173-01
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Injectable Medication
- Affected units
- 16
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 130 recalled by Mckesson Medical-Surgical Inc. Corporate Office 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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