Martin Avenue Pharmacy Recalls Sodium Tetradecyl Sulfate Injectable
Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations 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 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. This recall includes Sodium tetradecyl sulfate 5% (PF) injectable packaged in an amber glass injectable vial. The affected lots are 08062014@32 (Exp 9/5/2014) and 08072014@62 (Exp 9/6/2014).
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 products. The distribution pattern for the recalled items is nationwide.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the products are found, they should be discontinued and returned to the pharmacy or disposed of according to local regulations. No specific instructions for consumer action beyond identifying the affected lots are provided in the source text.
The recalled product
- Product
- Sodium tetradecyl sulfate 5% (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 (4)
- Lot Number: 08062014@32
- Exp 9/5/2014
- 08072014@62
- Exp 9/6/2014
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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