Gentamycin Injection Recalled Due to Sterility Assurance Concerns
Natures Pharmacy & Compounding Center is recalling all lots of Gentamycin 80mg/1000cc 0.9% NS 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 agency classification is FDA Class II. According to the rubric, FDA Class II recalls with potential for significant injury or hospitalization (implied by sterility failure in injectable drugs) map to a score of 4 (Severe).
Plain-English summary
Natures Pharmacy & Compounding Center is recalling all lots of Gentamycin 80mg/1000cc 0.9% NS that are not expired. The recall was initiated due to concerns regarding quality control procedures that present a potential risk to sterility assurance. These concerns were identified during a recent FDA inspection.
The recall covers all lots of sterile products compounded by the pharmacy that are within their expiration dates. The distribution pattern is listed as NC, and the code information indicates that all lot numbers within expiry are affected.
Consumers and healthcare providers should stop using the recalled product and contact the recalling firm or their healthcare provider for further instructions. The FDA classifies this recall as Class II, indicating a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Gentamycin 80mg/1000cc 0.9% NS
- Manufacturer
- Natures Pharmacy & Compounding Center
- Category
- Drug — Injectable
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 (1)
- All lot numbers within expiry.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 48 recalled by Natures Pharmacy & Compounding Center 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.
See all 48 products in this recall →Related recalls
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