Martin Avenue Pharmacy Recalls Hyaluronidase Injection Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling hyaluronidase injection solution due to quality control issues that may compromise sterility.
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 to sterility assurance for a sterile injectable product, which is a high-risk hazard 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 within their expiry dates. The specific product identified in the recall notice is Hyaluronidase injection solution (PF) 150 U/mL, packaged in amber glass injectable vials. The recall was initiated following a recent FDA inspection that identified observations related to certain quality control procedures.
The recall is being conducted because these quality control 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 product should stop using it and contact their healthcare provider or the pharmacy for further instructions. The recall covers lots with specific expiration dates, including those expiring in November 2014 and February 2015.
The recalled product
- Product
- Hyaluronidase injection solution (PF) 150 U/mL injectable 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 (4)
- Lot Number: 05232014@32
- Exp 11/19/2014
- 08192014@48
- Exp 2/15/2015
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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