Dihydroergotamine Mesylate Injection recalled due to discoloration
Provepharm Inc. is voluntarily recalling Dihydroergotamine Mesylate Injection nationwide due to discoloration in specific lots. Patients should contact their healthcare provider if they have used the affected product.
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: FDA Class II classification indicates potential for adverse health effects, but the absence of reported illnesses, injuries, or hospitalizations, combined with the firm's voluntary and precautionary recall initiation, supports a Moderate rating. The identified hazard—discoloration—represents a quality defect.
Plain-English summary
Provepharm Inc. is voluntarily recalling Dihydroergotamine Mesylate Injection, a prescription medication administered by injection. The recall affects approximately 10,800 ampules distributed nationwide within the United States due to discoloration identified in the product.
The recall involves two specific lots: F9026F01 and F9026F02, with an expiration date of 12/2025. These lots were distributed as 2,160 packs containing 5 ampules each.
Patients who have received injections from the affected lots should contact their healthcare provider immediately for guidance. Healthcare providers should check whether they have received any of the affected lots and follow appropriate product handling procedures.
The recalled product
- Product
- DIHYDROERGOTAMINE MESYLATE (DIHYDROERGOTAMINE MESYLATE)
- Brand
- DIHYDROERGOTAMINE MESYLATE
- Manufacturer
- Provepharm Inc.
- Category
- Drug — Injection
- Hazard
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 (3)
- Lot #: F9026F01
- F9026F02
- Exp. Date 12/2025
UPCs (1)
- 0381284411059
Distribution
Distributed nationwide across the United States.
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