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.
Check against the official notice below — it lists the full affected range.
Teva Pharmaceuticals USA is recalling Metoclopramide Injection USP 10 mg/2 mL (5 mg/mL) in 2 mL single-use vials due to a lack of sterility assurance. The recall affects 29,357 vials across six lot numbers with expiration dates ranging from February 2021 through December 2021. The manufacturing areas for these products exceeded acceptable levels for microbial recovery, which means the sterile injectable products cannot be guaranteed to be free from contamination. The product was distributed nationwide in the USA and Puerto Rico.
The affected lot numbers are 31325042B (exp. 06/2021), 31325336B (exp. 07/2021), 31326042B (exp. 10/2021), 31326137B (exp. 11/2021), 31326230B (exp. 12/2021), and 31323816B (exp. 02/2021). The source document does not specify what remedy consumers should pursue.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Product was distributed nationwide in the USA and Puerto Rico. Quantity: 29,357 vials Lot/code info: Lot # 31325042B, exp. date 06/2021 31325336B, exp. date 07/2021 31326042B, exp. date 10/2021 31326137B, exp. date 11/2021 31326230B, exp. date 12/2021 31323816B, exp. date 02/2021
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.