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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. The hazard involves a lack of assurance of sterility in compounded sterile preparations, which is a significant risk of harm (infection) even if specific injuries are not yet reported in the text, fitting the 'Severe' criteria for significant injury risk or structural/quality defects in medical products.
Plain-English summary
Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations that are within their expiration dates. The recall is being initiated in connection with a recent FDA inspection.
The recall was triggered by 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, other than the general category of compounded sterile preparations.
Consumers who have purchased these products should contact Martin Avenue Pharmacy, Inc. for further instructions on how to return the product or obtain a replacement. The source text does not provide specific contact information or a return address.
The recalled product
- Product
- Tacrolimus oil 0.03% opthalmic solution packaged in an opaque squeeze bottle eye dropper, 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: 08072014@63
- 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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