Gentamicin Irrigation Syringes Recalled for Lack of Sterility Assurance
Anderson Compounding Pharmacy is recalling Gentamicin irrigation syringes due to a lack of sterility assurance. The recall covers all lots distributed nationwide.
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 FDA classified this recall as Class II. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated Severe. Lack of sterility assurance in a medical product poses a significant risk of infection, aligning with the Severe criteria for significant injury reports or high-risk defects.
Plain-English summary
Anderson Compounding Pharmacy, Inc. is recalling Gentamicin 120 mg/250 mL 0.9% Sodium Chloride for Irrigation, 30 mL Syringe. The recall is being conducted because the product lacks sterility assurance.
The recall includes 6 syringes per unit and covers all lots. The product was distributed nationwide. The FDA has classified this recall as Class II.
Consumers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Gentamicin 120 mg/250 mL 0.9% Sodium Chloride for Irrigation, 30 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
- Hazard
- Affected units
- 6
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.
See all 68 products in this recall →Related recalls
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