Martin Avenue Pharmacy Recalls Prednisolone Acetate Injectable Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Prednisolone acetate 50 mg/mL injectable vials 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 an injectable drug, 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 Prednisolone acetate 50 mg/mL injectable packaged in amber glass vials. The affected product is identified by Lot Number 05082014@23 and has an expiration date of 11/4/2014. The recall covers 55 mL vials distributed nationwide.
The recall was initiated following a recent FDA inspection that identified observations associated with certain quality control procedures. These observations present a risk to the assurance of sterility for the compounded sterile preparations. The recall includes all compounded sterile preparations within their expiry dates.
Consumers and healthcare providers should stop using the affected product and contact Martin Avenue Pharmacy, Inc. for further instructions or a return. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Prednisolone acetate 50 mg/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 (2)
- Lot Number: 05082014@23
- Exp 11/4/2014
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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