Martin Avenue Pharmacy Recalls Testosterone Cypionate Injection Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Testosterone cypionate 150 mg/mL injections due to quality control issues that may compromise 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-of-harm product (sterility assurance failure in a sterile injection) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of Testosterone cypionate 150 mg/mL injection packaged in amber glass injectable vials. The affected product is identified by Lot Number 08202014@4 and has an expiration date of 11/18/2014. The recall covers all compounded sterile preparations within their expiry dates.
The recall was initiated following a recent FDA inspection that identified observations associated with certain quality control procedures. These procedural issues present a risk to the assurance of sterility for the compounded preparations. The source text does not specify the number of units recalled or report any illnesses or injuries associated with the product.
Consumers who have this specific lot of Testosterone cypionate injection should stop using it and contact their healthcare provider or the pharmacy for further instructions. The recall is being conducted voluntarily by Martin Avenue Pharmacy, Inc.
The recalled product
- Product
- Testosterone cypionate 150 mg/mL injection packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
- Manufacturer
- Martin Avenue Pharmacy, Inc.
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: 08202014@4
- Exp 11/18/2014
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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