Teva Recalls Leucovorin Calcium Injection Due to Sterility Concerns
Teva Pharmaceuticals is recalling Leucovorin Calcium for Injection because manufacturing areas exceeded microbial recovery levels, compromising sterility assurance.
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 recall is classified as FDA Class II and involves a lack of sterility assurance for injectable products, which poses a significant risk of infection or serious injury.
Plain-English summary
Teva Pharmaceuticals USA is recalling Leucovorin Calcium for Injection, USP, 100 mg/vial, Single-Dose Vial (NDC 0703-5140-01). The recall involves 248,565 vials distributed nationwide in the USA and Puerto Rico. Affected lots include 31326364B (exp. 01/2022), 31327120B (exp. 05/2022), and 31327963B (exp. 10/2022).
The recall was initiated due to a lack of assurance of sterility. Manufacturing areas for these products exceeded acceptance levels for microbial recovery, which means the sterile injectable products may not be sterile.
Healthcare providers and patients should stop using the affected vials and contact Teva Pharmaceuticals USA for further instructions or replacement.
The recalled product
- Product
- Leucovorin Calcium for Injection, USP, 100 mg/vial, Single-Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-5140-01.
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Injectable Medication
- Affected units
- 248,565
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 (4)
- Lot # 31326364B
- exp. date 01/2022 31327120B
- exp. date 05/2022 31327963B
- exp. date 10/2022
Distribution
Part of a larger recall action
This product is one of 15 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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