Martin Avenue Pharmacy Recalls Acetylcysteine Inhalant Solution Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Acetylcysteine 20% inhalant solution due to quality control issues affecting 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, which corresponds to a Severe severity score under the rubric, particularly given the risk to sterility assurance in a sterile preparation.
Plain-English summary
Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of Acetylcysteine 20% (PF) inhalant solution. The affected product is packaged in 3 mL or 7 mL vials and was distributed nationwide. The recall covers 450 mL of the product from specific lots with expiration dates in 2014.
The recall was initiated following an FDA inspection that identified observations associated with certain quality control procedures. These issues present a risk to the assurance of sterility for the compounded sterile preparations. The agency classification for this recall is Class II.
Consumers and healthcare providers should stop using the recalled product and contact Martin Avenue Pharmacy for further instructions or a replacement. The recall is limited to the specific lot numbers and expiration dates identified in the official notice.
The recalled product
- Product
- Acetylcysteine 20% (PF) inhalant solution packaged in either a 3 mL or 7 mL 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: 07022014@43
- Exp 9/30/2014
- 08052014@1
- Exp 11/3/2014
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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