Class II · Moderate risk
Dihydroergotamine Mesylate
cGMP deviations: Temperature abuse
Dihydroergotamine Mesylate Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Discoloration
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
Dihydroergotamine Mesylate Injection, solution for injection, USP, 1 mg/mL Ampules, Rx Only, Distributed by: Provepharm Inc. 100 Springhouse Drive Suite 105, Collegeville, PA 19426, NDC 81284-411-05
Affected NDC
81284-0411-05
Compare with the code on your package — it is the most precise check available.
Drug: Dihydroergotamine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Dihydroergotamine Mesylate NDC 81284-0411 |
1 mg/mL | Injection, Solution Intramuscular|intravenous|subcutaneous |
Provepharm Inc. | Rx |
- Recalling firm
- Provepharm Inc.
- NDC code
- 81284-411-05
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0150-2025 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Dihydroergotamine recalls
See all
Class II · Moderate risk
Dihydroergotamine Mesylate
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Dihydroergotamine mesylate 1 mg/mL injection solution packaged in…
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Other recalls by Provepharm Inc.
All 2024 recalls
Class I · High risk
Phenylephrine HCl Injection
Presence of Particulate Matter.
Other failed specification recalls from 2024
All failed specification recalls
Class I · High risk
Prograf (tacrolimus)
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Class I · High risk
Astagraf XL
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Class III · Low risk
Methadone Hydrochloride Tablets
Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
Class II · Moderate risk
Dapsone Gel 7.5%
Crystallization
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