Martin Avenue Pharmacy Recalls Sodium Tetradecyl Sulfate Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations of 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 involves a risk to sterility assurance for injectable products, which is a high-risk hazard where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within their expiry dates. The specific product involved is Sodium tetradecyl SO4 stock solution 6% solution, packaged in amber glass injectable vials. The recall is being initiated in connection with a recent FDA inspection.
The recall is due to observations associated with certain quality control procedures that present a risk to sterility assurance. The source text does not specify the number of units recalled, specific distribution locations beyond the manufacturer's address, or any reported illnesses or injuries.
Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions. The recall covers specific lot numbers with expiration dates ranging from November 2014 to February 2015.
The recalled product
- Product
- Sodium tetradecyl SO4 stock solution 6% 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 (8)
- Lot Number: 05142014@16
- Exp 11/10/2014
- 07142014@47
- Exp 1/10/2015
- 07152014@18
- Exp 1/11/2015
- 08062014@16
- Exp 2/2/2015
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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