Martin Avenue Pharmacy Recalls Compounded Sterile Preparations for Sterility Assurance Concerns
Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including sodium tetradecyl sulfate, due to quality control issues affecting 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 fits the rubric for high-risk products where injury has not yet been reported.
Plain-English summary
Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within their expiry dates. This recall includes sodium tetradecyl sulfate 2% (PF) injectable packaged in amber glass vials. The products were 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 preparations.
Consumers who have these products should stop using them and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- Sodium tetradecyl sulfate 2% (PF) injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
- Manufacturer
- Martin Avenue Pharmacy, Inc.
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: 08112014@50
- Exp 9/10/2014
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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