Martin Avenue Pharmacy Recalls Morphine Sulfate Syringes for Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling compounded morphine sulfate 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 (3).
Plain-English summary
Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within their expiry dates. The specific product identified in the recall notice is Morphine sulfate (PF) 3 mg/mL injectable, packaged in 30 mL or 60 mL syringes. The recall is associated with Lot Number 07242014@28, which has an expiration date of 10/22/2014.
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. The source text does not specify the exact nature of the quality control failures or the specific pathogens involved, only that the sterility assurance is at risk.
The distribution pattern for these products is listed as nationwide. Consumers and healthcare providers who possess this specific lot of morphine sulfate should stop using it and contact Martin Avenue Pharmacy or their healthcare provider for further instructions. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Morphine sulfate (PF) 3 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: 07242014@28
- Exp 10/22/2014
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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