Martin Avenue Pharmacy Recalls Phenol 10% Injectable Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Phenol 10% 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 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 recall is classified as FDA Class II and involves a risk to sterility assurance for injectable products, which aligns with the rubric criteria for Severe severity involving significant injury risks or Class II classifications with potential for serious harm.
Plain-English summary
Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of Phenol 10% injectable products packaged in amber glass vials. The affected products are 50 mL vials with lot numbers 06062014@44 (expiring September 4, 2014) and 07302014@14 (expiring October 28, 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 observations present a risk to the assurance of sterility for the products. The agency classification for this recall is Class II.
The products were distributed nationwide. Consumers and healthcare providers should stop using the affected vials and contact Martin Avenue Pharmacy, Inc. for further instructions or a refund.
The recalled product
- Product
- Phenol 10% 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: 06062014@44
- Exp 9/4/2014
- 07302014@14
- Exp 10/28/2014
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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