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.
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 the hazard involves a risk to sterility assurance for injectable products, which fits the criteria for high-risk products where injury has not yet been reported.
Plain-English summary
Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within their expiry dates. This action is being taken in connection with a recent FDA inspection.
The recall was initiated due to observations associated with certain quality control procedures that present a risk to sterility assurance. The specific product identified in the recall notice is chorionic gonadotropin buffered diluent solution packaged in an amber glass injectable vial, with a quantity of 500 mL. The distribution pattern is listed as nationwide.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If you have these products, you should stop using them and contact Martin Avenue Pharmacy or your healthcare provider for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Chorionic gonadotropin buffered diluent 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: 03182014@24
- Exp 9/14/2014
- 04012014@31
- Exp 9/28/2014
- 06032014@30
- Exp 11/30/2014
- 07292014@28
- Exp 1/25/2015
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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