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Class II: temporary or reversible health riskTerminated

Teva Pharmaceuticals Norepinephrine Bitartrate Injection 4 mg/4 mL Recall

Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose Vials, 10…

Teva Pharmaceuticals USA · Parsippany, NJ

Risk level
Class II
Reported by FDA
Jan 19, 2022
Recall ID
D-0371-2022
Check your lot numberHow we source this data

Summary

Teva Pharmaceuticals recalled Norepinephrine Bitartrate Injection 4 mg/4 mL starting Dec 31, 2021. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0371-2022 on Jan 19, 2022. Reason: Lack of Assurance of Sterility. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility

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.

Lot numbers, UPCs & expiration codes

Lot # 100020800, exp 07/2022

Where it was sold

Methylprednisolone, TN Norepinephrine BItartrate - MS, OH

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0371-2022
Classification
Class II
Status
Terminated
Recall initiated
Dec 31, 2021
FDA report date
Jan 19, 2022
Quantity
11,450 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Teva Pharmaceuticals USA

Original FDA data

Every field from FDA enforcement report D-0371-2022, exactly as published.

Show all FDA fields
City
Parsippany
State
NJ
Status
Terminated
Country
United States
Event ID
89326
Address
400 Interpace Pkwy
Code information
Lot # 100020800, exp 07/2022
Postal code
07054-1120
Report date
Jan 19, 2022
Product type
Drugs
Recall number
D-0371-2022
Classification
Class II
Recalling firm
Teva Pharmaceuticals USA
Product quantity
11,450 vials
Termination date
Jun 4, 2024
Reason for recall
Lack of Assurance of Sterility
Voluntary / mandated
Voluntary: Firm initiated
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.
Distribution pattern
Methylprednisolone, TN Norepinephrine BItartrate - MS, OH
Recall initiation date
Dec 31, 2021
Initial firm notification
Letter
Center classification date
Jan 13, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0371-2022, published Jan 19, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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