FDA-Drug2021-03-03Class II
Leucovorin Calcium for Injection, USP, 100 mg/vial, Single-Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-5140-01.
Teva Pharmaceuticals USA
Hazard
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Sold states
Product was distributed nationwide in the USA and Puerto Rico.
Affected count
248,565 vials
Manufactured in
400 Interpace Pkwy, N/A, Parsippany, NJ, United States
Products
Leucovorin Calcium for Injection, USP, 100 mg/vial, Single-Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-5140-01.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0276-2021Don't want to check this manually?
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