Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including Quad mix, 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 is classified as FDA Class II and involves a risk to sterility assurance for injectable products, which poses a significant risk of harm (infection) even though no specific illnesses or injuries are reported in the source text.
Plain-English summary
Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within their expiry dates. This recall includes the Quad mix injectable (papaverine, phentolamine mesylate, alprostadil, atropine) packaged in clear glass vials. The recall is being initiated following a recent FDA inspection that identified observations associated with certain quality control procedures.
The agency determined that these quality control issues present a risk to sterility assurance. The recall covers products distributed nationwide. Specific lot numbers and expiration dates for the affected Quad mix include Lot 06052014@16, expiring on September 15, 2014.
Consumers and healthcare providers should stop using the recalled products and contact Martin Avenue Pharmacy or their healthcare provider for further instructions on disposal or replacement.
The recalled product
- Product
- Quad mix, 30 mg/1 mg/20 mcg/0.15 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 (2)
- Lot Number: 06052014@16
- Exp 9/15/2014
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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