Martin Avenue Pharmacy Recalls Quad Mix Injectable Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Quad Mix injectable vials due to quality control observations that present a risk to 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 is classified as FDA Class II and involves a risk to sterility assurance, which is a high-risk hazard for injectable products, but the source text does not report any illnesses or injuries.
Plain-English summary
Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within their expiry dates. The specific product identified is Quad mix, 18 mg/0.2 mg/10 mcg/0.02 mg/mL (papaverine, phentolamine mesylate, alprostadil, atropine) injectable, packaged in a clear glass injectable vial. The affected lots are 07302014@29 (Exp 10/28/2014) and 08192014@31 (Exp 11/17/2014). The product was distributed nationwide.
The recall was initiated in connection with a recent FDA inspection. During the inspection, observations were made regarding certain quality control procedures that present a risk to sterility assurance. The agency classification for this recall is Class II.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If you have this product, you should stop using it and contact Martin Avenue Pharmacy, Inc. or your healthcare provider for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Quad mix, 18 mg/0.2 mg/10 mcg/0.02 mg/mL (papaverine, phentolamine mesylate, alprostadil, atropine) injectable packaged in a clear 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: 07302014@29
- Exp 10/28/2014
- 08192014@31
- Exp 11/17/2014
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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