Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling all compounded sterile preparations within expiry due to quality control observations that present a risk to sterility assurance.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 compounded sterile preparations, which is a high-risk product category 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 that are within their expiry dates. This action is being taken in connection with a recent FDA inspection.
The recall was initiated because of observations associated with certain quality control procedures that present a risk to sterility assurance. The source text does not specify which specific products or lot numbers are included in this recall, nor does it state the number of units affected.
Consumers who have purchased compounded sterile preparations from Martin Avenue Pharmacy should contact the pharmacy or their healthcare provider for instructions on how to proceed. The source text does not provide specific contact information or a list of affected products.
The recalled product
- Product
- Cyclosporine 200 mg/mL opthalmic suspension 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: 07152014@14
- Exp 10/13/2014
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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