Martin Avenue Pharmacy Recalls Fentanyl/Bupivacaine Injectable Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling fentanyl/bupivacaine injectable syringes due to quality control observations that present a risk to sterility assurance.
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 an injectable drug, which is a high-risk product category. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (Score 3).
Plain-English summary
Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within their expiry date. This recall specifically includes fentanyl/bupivacaine 3000 mcg/30 mg/mL injectable packaged in 30 mL or 60 mL syringes. The affected lot number is 08202014@31 with an expiration date of 9/19/2014.
The recall was initiated following a recent FDA inspection. During the inspection, observations were made regarding certain quality control procedures that present a risk to the assurance of sterility for the compounded preparations. The source text does not report any specific illnesses or injuries associated with this recall.
The distribution pattern for the affected product is nationwide. Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for further instructions on disposal or replacement.
The recalled product
- Product
- Fentanyl/bupivacaine 3000 mcg/30 mg/mL injectable packaged in 30 mL or 60 mL syringes, 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: 08202014@31
- Exp 9/19/2014
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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