Gentamicin Irrigation Recalled for Lack of Sterility Assurance
The Medicine Shoppe Pharmacy is recalling Gentamicin 80mg/60 mL Irrigation containers due to a lack of assurance of sterility.
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 sterility assurance for a medical irrigation product, which poses a significant risk of infection or injury.
Plain-English summary
The Medicine Shoppe Pharmacy is recalling four bottles of Gentamicin 80mg/60 mL Irrigation. The recall is being conducted because there is a lack of assurance of sterility for the product.
The affected product is identified by code 7016542 and has a discard after date of 01/12/2021. The recall is limited to distribution in Florida.
Consumers who have this product should stop using it and contact the pharmacy for further instructions.
The recalled product
- Product
- Gentamicin 80mg/60 mL Irrigation, containers, The Medicine Shoppe, 3524 B Tamiami Trail Port Charlotte, FL 33952
- Manufacturer
- The Medicine Shoppe Pharmacy
- Category
- Drug — Pharmacy Compounded
- Affected units
- 4
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)
- 7016542
- discard after 01/12/2021
Distribution
Distributed in 1 state:
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