Gentamicin Irrigation Recalled for Lack of Sterility Assurance
Anderson Compounding Pharmacy is recalling Gentamicin 250 mg/1000 mL Irrigation due to a lack of sterility assurance. The recall covers 4 bottles distributed nationwide.
What this means for you
Illness, injury, or structural failure has been reported. 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 medical product, which aligns with the 'Severe' criteria for significant injury risk or structural defects in medical contexts.
Plain-English summary
Anderson Compounding Pharmacy, Inc. is recalling 4 bottles of Gentamicin 250 mg/1000 mL Irrigation. The product was distributed nationwide. The recall was initiated because the product lacks sterility assurance.
The recall applies to all lots of the product. No specific dates or additional distribution details are provided in the source text.
Consumers who have this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- Gentamicin 250 mg/1000 mL Irrigation, 1000 mL, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
- Category
- Drug — Compounded Medication
- Hazard
- 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 (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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