Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including cyanocobalamin, due to quality control observations that risk sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states the agency classification is Class II. According to the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when associated with risks to sterility assurance which can lead to serious injury.
Plain-English summary
Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within their expiry dates. This recall includes Cyanocobalamin 1000 mcg/mL injectable solution packaged in amber glass vials, specifically Lot Number 08082014@9 with an expiration date of 11/6/2014. The affected products were distributed nationwide.
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 compounded preparations. The agency has classified this recall as Class II.
Consumers and healthcare providers should stop using the affected products and contact Martin Avenue Pharmacy, Inc. for further instructions or a refund. The recall is voluntary and is being conducted by the pharmacy to address the identified quality control issues.
The recalled product
- Product
- Cyanocobalamin 1000 mcg/mL injectable solution 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 (2)
- Lot Number: 08082014@9
- Exp 11/6/2014
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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