Martin Avenue Pharmacy Recalls Dexamethasone Sodium Phosphate Injectable Vials
Martin Avenue Pharmacy is voluntarily recalling dexamethasone sodium phosphate injectable vials due to quality control issues that risk 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 where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of dexamethasone sodium phosphate 24 mg/mL injectable vials. The affected product is packaged in amber glass vials and is distributed nationwide. The specific lot number is 08122014@14, with an expiration date of 2/8/2015.
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 sterile preparations. The recall covers all compounded sterile preparations within their expiry date.
Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be discontinued from use and returned to the pharmacy or disposed of according to local regulations. No specific instructions for consumer disposal are provided in the source text.
The recalled product
- Product
- Dexamethasone sodium phosphate 24 mg/mL injectable 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: 08122014@14
- Exp 2/8/2015
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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