Agency classClass IIOur severity:Severe FDA (Drugs)·D-0374-2021·Announced 2021-05-26

Teva Recalls Leucovorin Calcium Injection Due to Sterility Concerns

Teva Pharmaceuticals is recalling specific lots of Leucovorin Calcium for Injection because the company cannot guarantee the product is sterile.

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: The recall is classified as FDA Class II and involves a lack of assurance of sterility in an injectable drug, which poses a risk of serious infection or adverse health consequences, meeting the criteria for a Severe rating.

Plain-English summary

Teva Pharmaceuticals USA is recalling specific lots of Leucovorin Calcium for Injection, 350 mg/vial (20 mg/mL). The recall is being conducted because the company lacks assurance of the sterility of the affected product. The product is a prescription-only sterile injection intended for intramuscular or intravenous use.

The recall involves 192,277 cartons, each containing a single-dose vial. The affected product was distributed nationwide. Specific lots include NDC 0703-5145-01 (Lot # 31325332B, exp. 08/2021; Lot # 31325756B, exp. 09/2021) and NDC 0703-5145-91 (Lot # 31325685B, exp. 09/2021). The product is also labeled under the Novaplus brand.

Healthcare providers and patients should stop using the affected lots and contact Teva Pharmaceuticals USA for further instructions or replacement product. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: Leucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial (20 mg/mL), Rx Only, FOR IM or IV Use, Sterile, Teva Parenteral Medicines, Inc., Irvine, CA NDC 0703-5145-01; ALSO LABELED UNDER: NOVAPLUS, Manufactured By: Teva Pharmaceuticals USA, Inc., North Wales, PA…
Manufacturer: Teva Pharmaceuticals USA
Category: Drug — Injectable
Hazard: sterility

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 (5)

NDC 0703-5145-01: Lot # 31325332B
exp. date 08/2021
Lot # 31325756B
exp. date 09/2021 AND NDC 0703-5145-91: Lot # 31325685B
exp. date 09/2021

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 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.

See all 5 products in this recall →

Same manufacturer · Teva Pharmaceuticals USA

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Same hazard · sterility