FDA-Drug2021-03-03Class II
Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial NDC 0703-4502-01), packaged in 25 x 2 mL Single-Use Vials per tray (NDC 0703-4502-04), Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618.
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
29,357 vials
Manufactured in
400 Interpace Pkwy, N/A, Parsippany, NJ, United States
Products
Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial NDC 0703-4502-01), packaged in 25 x 2 mL Single-Use Vials per tray (NDC 0703-4502-04), Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0277-2021Don't want to check this manually?
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