Amikacin Sulfate Injection Recalled Due to Sterility Assurance Failure
Teva Pharmaceuticals USA is recalling Amikacin Sulfate Injection USP 1 gram/4mL vials nationwide due to lack of assurance of sterility. The recall affects 4,712 vials with lot #31329243B and expiration date 05/2022.
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: This is an FDA Class II recall of a sterile injectable pharmaceutical product. Lack of sterility assurance in injectables poses a direct risk of serious infection, which meets the Class II criterion for severity in a pharmaceutical context where harm from contamination could result in hospitalization.
Plain-English summary
Teva Pharmaceuticals USA is recalling Amikacin Sulfate Injection USP 1 gram/4mL (250mg/mL), 4 mL single-dose vials, due to lack of assurance of sterility. The product is an injectable antibiotic (Rx only, NDC 0703-9040-01) manufactured by Teva Pharmaceuticals USA Inc., North Wales, PA 19454.
The affected lot (#31329243B with expiration date 05/2022) consisted of 4,712 vials distributed nationwide, including Puerto Rico. Because sterility cannot be assured, there is potential for serious infection risk if contaminated product is administered to patients.
Patients and healthcare providers who have this product should not use it. Affected consumers should contact their pharmacy or healthcare provider immediately. Healthcare facilities should quarantine and return the recalled product to the manufacturer or distributor.
The recalled product
- Product
- Amikacin Sulfate Injection USP 1 gram/4mL (250mg/ML), 4 mL single-dose vials, Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0703-9040-01
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Injectable Antibiotic
- Affected units
- 4,712
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)
- Lot #: 31329243B
- exp. date 05/2022
Distribution
Part of a larger recall action
This product is one of 19 recalled by Teva Pharmaceuticals USA 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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