Leucovorin Calcium for Injection recalled for lack of sterility assurance
Teva Pharmaceuticals is recalling Leucovorin Calcium for Injection (350 mg/vial) distributed nationwide because the manufacturer cannot assure the product is sterile. Patients using recalled lot should consult their healthcare provider.
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 an injectable prescription drug with a sterility defect, which directly poses a significant risk of serious adverse health outcomes (infection, sepsis) if patients receive non-sterile medication. Although no illnesses are reported in the source text, the hazard—compromised sterility of an intravenous product—is inherently serious and meets the Severe threshold.
Plain-English summary
Teva Pharmaceuticals USA is recalling Leucovorin Calcium for Injection, USP (350 mg/vial, 17.5 mL single-use vials) because the manufacturer cannot provide assurance of sterility for the affected lot.
The recalled product is Lot #313282585B with expiration date 11/2022. A total of 42,046 vials were distributed nationwide, including Puerto Rico.
Patients who are currently using or have used this product should contact their healthcare provider immediately for guidance. Patients should not stop using their medication without first consulting a physician, as this is an injectable prescription drug. Healthcare facilities and pharmacies should quarantine remaining product from the affected lot and return it to the manufacturer or contact their wholesaler for instructions.
The recalled product
- Product
- Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Manufactured by: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-5145-91
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Injectable / Intravenous
- Affected units
- 42,046
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 #: 313282585B
- exp. date 11/2022
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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