Gentamicin Irrigation Recalled Due to Sterility Assurance Concerns
Nora Apothecary is recalling Gentamicin 24mg/60ml Irrigation because FDA inspections raised concerns about quality control and 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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in a medical product, which aligns with the rubric criteria for Severe severity (FDA Class II with potential for significant injury).
Plain-English summary
Nora Apothecary and Alternative Therapies, Inc. is recalling Gentamicin 24mg/60ml Irrigation, 15x60ml Syringe Irrigation, 14 day expiration. The recall is being conducted due to FDA inspection findings that resulted in concerns regarding quality control processes and the assurance of sterility.
The recall includes all products within their expiration date, specifically those dated 90 days prior to April 19, 2013 (January 2013 to April 19, 2013). The distribution pattern is listed as nationwide.
Consumers and healthcare providers should stop using the recalled product and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- Gentamicin 24mg/60ml Irrigation, 15x60ml Syr Irrigation, 14 day expiration,
- Manufacturer
- Nora Apothecary and Alternative Therapies, Inc.
- Category
- Drug — Antibiotic Irrigation
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)
- 2013 (Jan. 2013 to April 19
- 2013).
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 43 recalled by Nora Apothecary and Alternative Therapies, 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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