Martin Avenue Pharmacy Recalls Benzalkonium Chloride Injection Vials
Martin Avenue Pharmacy is voluntarily recalling benzalkonium chloride water for injection 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 an injectable product, which fits the 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 benzalkonium chloride water for injection packaged in amber glass injectable vials. The affected product is a 30 mL compounded sterile preparation with Lot Number 04292014@19 and an expiration date of 10/26/2014. 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 agency classification for this recall is Class II. The distribution pattern is listed as nationwide.
Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If the product is found, it should be returned to the pharmacy or disposed of according to local regulations. No specific instructions for consumer action beyond identifying the product are provided in the source text.
The recalled product
- Product
- Benzalkonium chloride water for injection 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: 04292014@19
- Exp 10/26/2014
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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