Martin Avenue Pharmacy Recalls Fentanyl Injectable Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling fentanyl injectable 6000 mcg/mL 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 an injectable drug, 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 fentanyl injectable 6000 mcg/mL packaged in 30 mL or 60 mL syringes. The recall covers all compounded sterile preparations within their expiry date.
The recall was initiated following a recent FDA inspection. The agency observed certain quality control procedures that present a risk to sterility assurance. The specific lot number is 08142014@45, with an expiration date of 11/12/2014.
The product was distributed nationwide. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or Martin Avenue Pharmacy for further instructions.
The recalled product
- Product
- Fentanyl injectable 6000 mcg/mL packaged in 30 mLor 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
- Manufacturer
- Martin Avenue Pharmacy, Inc.
- Category
- Drug — Injectable
- 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: 08142014@45
- Exp 11/12/2014
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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