FDA Recalls Dihydroergotamine Mesylate Injection for Temperature Abuse
McKesson Medical-Surgical is recalling Dihydroergotamine Mesylate Injection (NDC 0574-0850-10) due to temperature deviations during manufacturing that may affect product quality. The drug was distributed nationwide.
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 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: This is an FDA Class II recall for manufacturing deviations (temperature abuse) affecting product quality. No illnesses or injuries have been reported, consistent with a voluntary precautionary recall.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Dihydroergotamine Mesylate, Injection, USP, 1mg/mL, packaged in boxes of 5 x 1 mL ampules (NDC 0574-0850-10), manufactured for Perrigo, Minneapolis, MN. This is a prescription pharmaceutical injection.
The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations involving temperature abuse during the manufacturing process. These deviations may affect product quality.
The affected product was distributed nationwide throughout the United States. McKesson Medical-Surgical Inc. was unable to identify specific lot numbers received by individual customers and instead sent notifications directly with shipping date information relevant to each customer's orders.
Customers who received this product should contact their healthcare provider or pharmacy for guidance.
The recalled product
- Product
- Dihydroergotamine Mesylate, Injection, USP, 1mg/mL, packaged in box of 5 x 1 mL ampules, Rx only, Manufactured for: Perrigo, Minneapolis, MN, NDC 0574-0850-10
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug
- Affected units
- 1
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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