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Class II: temporary or reversible health riskTerminated

SterRx Norepinephrine 32 mg per 250 mL Recall

Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0

SterRx, LLC · Plattsburgh, NY

Risk level
Class II
Reported by FDA
Jul 26, 2023
Recall ID
D-0934-2023
Check your lot numberHow we source this data

Summary

SterRx recalled Norepinephrine 32 mg per 250 mL starting Jul 7, 2023. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0934-2023 on Jul 26, 2023. Reason: Lack of Assurance of Sterility. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility

Product description

Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-702-01.

Lot numbers, UPCs & expiration codes

Lot #: 490100, Exp 27-Jul-23

Where it was sold

Nationwide in the USA

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-0934-2023
Classification
Class II
Status
Terminated
Recall initiated
Jul 7, 2023
FDA report date
Jul 26, 2023
Quantity
2,088 bags
Recall type
Voluntary: Firm initiated
Recalling firm
SterRx, LLC

Original FDA data

Every field from FDA enforcement report D-0934-2023, exactly as published.

Show all FDA fields
City
Plattsburgh
State
NY
Status
Terminated
Country
United States
Event ID
92657
Address
141 Idaho Ave
Code information
Lot #: 490100, Exp 27-Jul-23
Postal code
12903-3987
Report date
Jul 26, 2023
Product type
Drugs
Recall number
D-0934-2023
Classification
Class II
Recalling firm
SterRx, LLC
Product quantity
2,088 bags
Termination date
Jul 8, 2024
Reason for recall
Lack of Assurance of Sterility
Voluntary / mandated
Voluntary: Firm initiated
Product description
Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-702-01.
Distribution pattern
Nationwide in the USA
Recall initiation date
Jul 7, 2023
Initial firm notification
Letter
Center classification date
Jul 19, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0934-2023, published Jul 26, 2023. 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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