FDAClass IIMay 26, 2021

Leucovorin Calcium for Injection recall: Sterility Concern

Leucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial (20 mg/mL), Rx Only, FOR IM or IV Use, Sterile, Teva Parenteral Medicines…

Why was Leucovorin Calcium for Injection recalled?

Lack of Assurance of Sterility

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Teva Pharmaceuticals USA
Quantity
192,277 cartons/1 single dose vial per carton
Distribution
Product was distributed nationwide.
Recall date
May 26, 2021
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls