FindMyRecallSubscribe
Class II: temporary or reversible health riskTerminated

SCA Pharmaceuticals NORepinephrine Bitartrate 8 mg in 0 Recall

NORepinephrine Bitartrate 8 mg in 0

SCA Pharmaceuticals · Little Rock, AR

Risk level
Class II
Reported by FDA
Aug 2, 2017
Recall ID
D-1021-2017
Check your lot numberHow we source this data

Summary

SCA Pharmaceuticals recalled NORepinephrine Bitartrate 8 mg in 0 starting Jul 14, 2017. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1021-2017 on Aug 2, 2017. Reason: Lack of Assurance of Sterility; product has the potential to leak. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility; product has the potential to leak.

Product description

NORepinephrine Bitartrate 8 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0774-40

Lot numbers, UPCs & expiration codes

Lots: 20170502@31 BUD: 7/16/2017; 20170508@34 BUD: 7/22/2017; 20170508@70 BUD: 7/22/2017; 20170512@15 BUD: 7/26/2017

Where it was sold

Nationwide

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-1021-2017
Classification
Class II
Status
Terminated
Recall initiated
Jul 14, 2017
FDA report date
Aug 2, 2017
Quantity
N/A
Recall type
Voluntary: Firm initiated
Recalling firm
SCA Pharmaceuticals

Original FDA data

Every field from FDA enforcement report D-1021-2017, exactly as published.

Show all FDA fields
City
Little Rock
State
AR
Status
Terminated
Country
United States
Event ID
77770
Address
8821 Knoedl Ct
Code information
Lots: 20170502@31 BUD: 7/16/2017; 20170508@34 BUD: 7/22/2017; 20170508@70 BUD: 7/22/2017; 20170512@15 BUD: 7/26/2017
Postal code
72205-4600
Report date
Aug 2, 2017
Product type
Drugs
Recall number
D-1021-2017
Classification
Class II
Recalling firm
SCA Pharmaceuticals
Termination date
May 1, 2019
Reason for recall
Lack of Assurance of Sterility; product has the potential to leak.
Voluntary / mandated
Voluntary: Firm initiated
Product description
NORepinephrine Bitartrate 8 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0774-40
Distribution pattern
Nationwide
Recall initiation date
Jul 14, 2017
Initial firm notification
Letter
Center classification date
Jul 26, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1021-2017, published Aug 2, 2017. 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.

How we source and update recall data · Report incorrect information

Other recent drug recalls