PlainRecalls
FDA Drug Moderate Class II Terminated

Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose Vials, 10 vials per carton, Rx Only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0703-1153-03.

Reported: January 19, 2022 Initiated: December 31, 2021 #D-0371-2022

Product Description

Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose Vials, 10 vials per carton, Rx Only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0703-1153-03.

Reason for Recall

Lack of Assurance of Sterility

Details

Recalling Firm
Teva Pharmaceuticals USA
Units Affected
11,450 vials
Distribution
Methylprednisolone, TN Norepinephrine BItartrate - MS, OH
Location
Parsippany, NJ

Frequently Asked Questions

What product was recalled?
Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose Vials, 10 vials per carton, Rx Only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0703-1153-03.. Recalled by Teva Pharmaceuticals USA. Units affected: 11,450 vials.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on January 19, 2022. Severity: Moderate. Recall number: D-0371-2022.