Martin Avenue Pharmacy Recalls Dexamethasone Sodium Phosphate Injectable Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Dexamethasone sodium phosphate 4 mg/mL injectable vials due to quality control observations that present a risk to sterility assurance.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the source text explicitly states that the quality control observations present a risk to sterility assurance, which aligns with the rubric criteria for Severe severity involving significant injury risks or Class II classifications with potential for serious harm.
Plain-English summary
Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of Dexamethasone sodium phosphate 4 mg/mL injectable packaged in amber glass vials. The recall covers specific lots with expiration dates of 9/30/2014 and 12/1/2014. The product was 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 sterile preparations.
Consumers and healthcare providers should stop using the affected product and contact Martin Avenue Pharmacy, Inc. for further instructions or a return.
The recalled product
- Product
- Dexamethasone sodium phosphate 4 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 (4)
- Lot Number: 04032014@13
- Exp 9/30/2014
- 06042014@5
- Exp 12/1/2014
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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