Martin Avenue Pharmacy Recalls Sodium Tetradecyl Sulfate Injectable Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling sodium tetradecyl sulfate 1% 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 for an injectable product, which fits the rubric criterion 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 all compounded sterile preparations within their expiry dates. This action specifically includes sodium tetradecyl sulfate 1% (PF) injectable packaged in amber glass vials, with a quantity of 10.5 mL. The affected lot number is 08182014@30, with an expiration date of 9/17/2014. The product was distributed nationwide.
The recall was initiated following a recent FDA inspection. During the inspection, observations were made regarding certain quality control procedures that present a risk to the assurance of sterility for the compounded preparations. The agency classification for this recall is Class II.
Consumers and healthcare providers who have this specific product should stop using it and contact Martin Avenue Pharmacy, Inc. or their healthcare provider for further instructions. The recall covers all compounded sterile preparations within expiry, not just the specific sodium tetradecyl sulfate product listed.
The recalled product
- Product
- Sodium tetradecyl sulfate 1% (PF) injectable 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 (2)
- Lot Number: 08182014@30
- Exp 9/17/2014
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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