Gentamicin Sterile Water Recall Due to Lack of Sterility Assurance
Anderson Compounding Pharmacy is recalling Gentamicin 240 mg/500 mL Sterile Water for Irrigation due to a lack of 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 hazard involves a lack of sterility assurance in a sterile irrigation solution, which poses a significant risk of infection.
Plain-English summary
Anderson Compounding Pharmacy, Inc. is recalling Gentamicin 240 mg/500 mL Sterile Water for Irrigation, 60 mL Syringe. The recall is being conducted because of a lack of sterility assurance for the product.
The affected product was distributed nationwide. The recall includes all lots of the medication. The product was manufactured by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy, located in Bristol, Tennessee.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Gentamicin 240 mg/500 mL Sterile Water for Irrigation,60 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
- 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 (1)
- All Lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 68 recalled by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy 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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