Leucovorin Calcium Injection Recalled Due to Sterility Concerns
Teva Pharmaceuticals is recalling Leucovorin Calcium for Injection (350 mg/vial) distributed nationwide because the manufacturer cannot assure the product meets sterility standards.
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 involving a parenteral (injectable) pharmaceutical product. Loss of sterility assurance in injectable medications poses serious risk of infection and potential hospitalization, meeting the Severe classification criterion.
Plain-English summary
Teva Pharmaceuticals USA is recalling Leucovorin Calcium for Injection, USP 350 mg/vial in 17.5 mL single-use vials. The recall affects approximately 434,229 vials that were distributed nationwide, including Puerto Rico. The recall is due to a lack of assurance of sterility.
The affected lot numbers are: 31325852B, 31325985B (exp. 10/2021); 31326349B (exp. 01/2022); 31326873B (exp. 03/2022); 31326995B (exp. 05/2022); 31327158B (exp. 06/2022); and 31328946B and 31329180B (exp. 05/2023). The product is distributed under the manufacturer Teva Parenteral Medicines, Inc., Irvine, CA 92618.
Patients and healthcare providers in possession of affected lots should consult with a healthcare professional regarding appropriate next steps. The product is prescription-only and is identified by NDC 0703-5145-01.
The recalled product
- Product
- Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5145-01
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Injectable / Parenteral
- Affected units
- 434,229
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 (13)
- Lot #: 31325852B
- 31325985B
- exp. date 10/2021
- 31326349B
- exp. date 01/2022
- 31326873B
- exp. date 03/2022
- 31326995B
- exp. date 05/2022 31327158B
- exp. date 06/2022
- 31328946B
- 31329180B
- exp. date 05/2023.
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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