The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0285-2021·Announced 2021-03-03

Teva Recalls Leucovorin Calcium Injection Due to Sterility Concerns

Teva Pharmaceuticals is recalling Leucovorin Calcium for Injection because manufacturing areas exceeded microbial acceptance levels, compromising sterility assurance.

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 the hazard involves a lack of sterility assurance in 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, 350 mg/vial, NDC 0703-5145-01. The recall involves 705,745 vials distributed nationwide in the USA and Puerto Rico. The product is labeled as Teva Parenteral Medicines, Inc., Irvine, CA, and manufactured by Teva Pharmaceuticals USA, Inc., North Wales, PA.

The recall was initiated due to a lack of assurance of sterility. According to the source, manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery. This condition led to a lack of sterility assurance for these sterile injectable products.

Healthcare providers and patients should stop using the affected lots and contact Teva Pharmaceuticals for further instructions. The specific lot numbers and expiration dates are listed in the recall documentation.

The recalled product

Product
Leucovorin Calcium for Injection, USP, 350 mg/vial, Rx only, labeled as a) Teva Parenteral Medicines, Inc., Irvine, CA 92618, and b) Manufactured By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, novaplus+, NDC 0703-5145-01.
Manufacturer
Teva Pharmaceuticals USA
Category
Drug — Injectable
Hazard
Affected units
705,745

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 (20)

  • Lot # a) 31324653B
  • exp. date 03/2021
  • 31326066B
  • exp. date 11/2021
  • 31326428B
  • exp. date 02/2022
  • 31327949B
  • exp. date 10/2022
  • 31327995B
  • 31328031B
  • exp. date 11/2022
  • 31328217B
  • exp. date 12/2022
  • 31328325B
  • 31328425B
  • exp. date 07/2021
  • Lot # b) 31324480B
  • exp. date 02/2021
  • Lot # 31327396B
  • exp. date 08/2022

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 15 products in this recall →

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