Idarubicin Hydrochloride Injection Recalled Due to Sterility Concerns
Teva Pharmaceuticals USA is recalling Idarubicin Hydrochloride Injection 20 mg/20 mL vials nationwide due to lack of assurance of sterility. The recall affects 2,091 vials distributed across the United States and Puerto Rico.
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: This is an FDA Class II recall involving a sterility defect in an injectable chemotherapy drug. Lack of sterility assurance in injectable medications poses risk of serious infection and potentially requires hospitalization, meeting the Severe criteria for Class II recalls with significant potential for harm.
Plain-English summary
Teva Pharmaceuticals USA is recalling Idarubicin Hydrochloride Injection 20 mg/20 mL (single-dose vials) due to lack of assurance of sterility. The affected product is NDC 0703-4156-11, Lot #31328668B with an expiration date of April 2023.
The recall affects 2,091 vials that were distributed nationwide, including Puerto Rico. Idarubicin hydrochloride is a chemotherapy medication used to treat cancer patients. Without assurance of sterility, there is a potential risk of serious infection if contaminated product is administered.
Patients currently using this medication should contact their healthcare provider immediately. Healthcare providers should quarantine remaining product from the affected lot and not dispense it to patients. Any product from Lot #31328668B should be returned to Teva Pharmaceuticals USA or disposed of according to applicable regulations.
The recalled product
- Product
- Idarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-4156-11
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Injectable Chemotherapy
- Affected units
- 2,091
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 #: 31328668B
- exp. date 04/2023
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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