FindMyRecallSubscribe
Class III: unlikely to cause harmTerminated

Pharmedium Services NORepinephrine Bitartrate Recall

NORepinephrine Bitartrate, 8 mg (32 mcg/mL) added to 250 mL 0

Pharmedium Services, LLC · Lake Forest, IL

Risk level
Class III
Reported by FDA
Mar 23, 2016
Recall ID
D-0778-2016
Check your lot numberHow we source this data

Summary

Pharmedium Services recalled NORepinephrine Bitartrate starting Dec 31, 2015. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0778-2016 on Mar 23, 2016. Reason: Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration. Status: Terminated.

Why it was recalled

Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration

Product description

NORepinephrine Bitartrate, 8 mg (32 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag Black, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-127-61

Lot numbers, UPCs & expiration codes

Service Code 2K6127; 15342123S, exp 2/10/2016 15349071S, exp 2/17/2016 and 15351050S, exp 2/19/2016

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-0778-2016
Classification
Class III
Status
Terminated
Recall initiated
Dec 31, 2015
FDA report date
Mar 23, 2016
Recall type
Voluntary: Firm initiated
Recalling firm
Pharmedium Services, LLC

Original FDA data

Every field from FDA enforcement report D-0778-2016, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
72973
Address
150 N Field Dr Ste 350
Code information
Service Code 2K6127; 15342123S, exp 2/10/2016 15349071S, exp 2/17/2016 and 15351050S, exp 2/19/2016
Postal code
60045-2506
Report date
Mar 23, 2016
Product type
Drugs
Recall number
D-0778-2016
Classification
Class III
Recalling firm
Pharmedium Services, LLC
Termination date
Apr 6, 2016
Reason for recall
Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
Voluntary / mandated
Voluntary: Firm initiated
Product description
NORepinephrine Bitartrate, 8 mg (32 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag Black, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-127-61
Distribution pattern
Nationwide
Recall initiation date
Dec 31, 2015
Initial firm notification
E-Mail
Center classification date
Mar 17, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0778-2016, published Mar 23, 2016. 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