Martin Avenue Pharmacy Recalls Alprostadil Alcohol Injectable Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Alprostadil alcohol injectable vials because quality control observations during an FDA inspection presented 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 source text explicitly states the agency classification is Class II. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe).
Plain-English summary
Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within their expiry dates. This recall specifically includes Alprostadil alcohol 500 mcg/mL injectable packaged in amber glass vials. The affected lots are 05022014@19, 05022014@28, 06122014@17, and 07302014@22, with expiration dates ranging from October 29, 2014, to January 26, 2015.
The recall was initiated following a recent FDA inspection. During this inspection, observations were made regarding certain quality control procedures that present a risk to the assurance of sterility for the compounded preparations. The agency has classified this recall as Class II.
The product was distributed nationwide. Consumers and healthcare providers should stop using the affected products and contact Martin Avenue Pharmacy or their healthcare provider for further instructions on disposal or replacement.
The recalled product
- Product
- Alprostadil alcohol 500 mcg/mL injectable packaged in 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 (7)
- Lot Number: 05022014@19
- Exp 10/29/2014
- 05022014@28
- 06122014@17
- Exp 12/9/2014
- 07302014@22
- Exp 1/26/2015
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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