Martin Avenue Pharmacy Recalls Dihydroergotamine Mesylate Injection Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling dihydroergotamine mesylate injections due to quality control issues that may compromise sterility assurance.
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: The recall involves a risk of harm (loss of sterility assurance) for a sterile injectable product, but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of dihydroergotamine mesylate 1 mg/mL injection solution packaged in amber glass injectable vials. The recall covers 510 mL of product distributed nationwide.
The recall was initiated following a recent FDA inspection that identified observations associated with certain quality control procedures. These observations present a risk to the assurance of sterility for the compounded sterile preparations.
Consumers should check their medication for the following lot numbers and expiration dates: Lot 06162014@34 (Exp 9/14/2014) and Lot 08142014@39 (Exp 11/12/2014). If you have this product, you should stop using it and contact your pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Dihydroergotamine mesylate 1 mg/mL injection solution packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
- Manufacturer
- Martin Avenue Pharmacy, Inc.
- 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 (4)
- Lot Number: 06162014@34
- Exp 9/14/2014
- 08142014@39
- Exp 11/12/2014
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 118 recalled by Martin Avenue Pharmacy, Inc. 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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