Leucovorin Calcium for Injection, USP 100 mg/vial, 10 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvi
Summary
The FDA issued a Class II for Leucovorin Calcium for Injection, USP 100 mg/vial, 10 mL single-use vials, Rx on by Teva Pharmaceuticals USA. Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-0746-2021
Action Date
2021-08-25
Status
Terminated
Category
drug
Product Description
Leucovorin Calcium for Injection, USP 100 mg/vial, 10 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5140-01
Lot/Code Info: Lot #: 31325596B, exp. date 08/2021; 31328129B, exp. date 11/2022; 31328356B, exp. date 01/2023; 31329297B, exp. date 06/2023; 31329569B, 31329821B, exp. date 08/2023
Quantity Affected: 476,275 vials
Reason for Recall
Lack of Assurance of Sterility
Distribution
Product was distributed Nationwide, including Puerto Rico.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-29
Company
Parsippany, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 55 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Teva Pharmaceuticals USA has 38 FDA actions in our database, including 38 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Teva Pharmaceuticals USA) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Teva Pharmaceuticals USA have FDA actions?
Teva Pharmaceuticals USA has 38 FDA actions in our database, including 38 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0746-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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