Anderson Compounding Pharmacy Recalls Gentamicin Sterile Water for Irrigation
Anderson Compounding Pharmacy is recalling Gentamicin 160 mg/1000 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 agency classification is FDA Class II, and the hazard involves a lack of sterility assurance in a sterile irrigation product, which poses a significant risk of infection and potential hospitalization, aligning with the 'Severe' criteria for significant injury reports or high-risk contamination.
Plain-English summary
Anderson Compounding Pharmacy, Inc. is recalling Gentamicin 160 mg/1000 mL Sterile Water for Irrigation, 1000 mL bottles. The recall was initiated because the product lacks sterility assurance.
The affected product is distributed nationwide. All lots of the product are included in this recall. The source text does not specify the number of units affected or the specific dates of distribution.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions. The source text does not provide specific contact information for the recalling firm.
The recalled product
- Product
- Gentamicin 160 mg/1000 mL Sterile Water for Irrigation,1000 mL Bottle, 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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