Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including morphine/bupivacaine, due to quality control issues affecting 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-of-harm product (sterile injectable) where injury has not yet been reported, fitting the High severity criteria for theoretical hazards without confirmed illness.
Plain-English summary
Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within their expiry dates. This recall includes morphine/bupivacaine 5 mg/2 mg/mL injectable packaged in 30 mL or 60 mL syringes. The specific lot identified is 08112014@51 with an expiration date of 9/10/2014.
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 affected products.
The products were distributed nationwide. Consumers and healthcare providers should stop using the recalled products and contact Martin Avenue Pharmacy or their healthcare provider for further instructions.
The recalled product
- Product
- Morphine/bupivacaine 5 mg/2 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: 08112014@51
- Exp 9/10/2014
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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