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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Pharmedium Services, LLC: Norepinephrine Bitartrate Injections Recalled for Being Subpotent

Agency Publication Date: December 23, 2019
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Summary

Pharmedium Services, LLC has recalled approximately 12,492 bags of Norepinephrine Bitartrate added to Dextrose Injections due to the drug being subpotent, meaning it may not contain the full strength of the medication required for treatment. These prescription intravenous medications were distributed nationwide to hospitals and healthcare facilities between late 2019 and early 2020. Because these products may not deliver the expected dose of Norepinephrine, patients may not receive the necessary cardiovascular support during critical care.

Risk

A subpotent drug may fail to provide the intended therapeutic effect, which for Norepinephrine—a medication used to treat life-threatening low blood pressure—could result in inadequate blood pressure control and poor patient outcomes. No specific injuries or incidents were reported in the recall data.

What You Should Do

  1. Check your medical supplies for PharMEDium Norepinephrine Bitartrate 8 mg added to 250 mL Dextrose (32 mcg/mL), 8 mg added to 500 mL Dextrose (16 mcg/mL), or 4 mg added to 250 mL Dextrose (16 mcg/mL) in Viaflex Bags.
  2. Verify the lot numbers on your packaging against the affected list, which includes lots such as 192930039S, 193040035S, and 192930026S with expiration dates ranging from December 2019 through January 2020.
  3. If you identify any of these affected products, stop using them immediately and set them aside to prevent accidental administration.
  4. Contact your healthcare provider or pharmacist immediately for guidance if you believe you or a patient has received a subpotent dose of this medication.
  5. Return any unused or remaining product to the pharmacy or healthcare facility where it was obtained for a refund and further instructions.
  6. Contact PharMedium Services, LLC at their Lake Forest, Illinois headquarters or via the distributor details for specific return and replacement instructions.
  7. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: NORepinephrine Bitartrate 8 mg added to 250 mL 5% Dextrose Injection USP (32 mcg per mL) Total Volume 258.00 mL Viaflex Bag
Model:
D-0625-2020
Lot Numbers:
192930039S (Exp. 12/18/19)
192930041S (Exp. 12/18/19)
192940048S (Exp. 12/19/19)
192940049S (Exp. 12/19/19)
192950031S (Exp. 12/20/19)
192950032S (Exp. 12/20/19)
192960039S (Exp. 12/22/19)
192960040S (Exp. 12/22/19)
192960041S (Exp. 12/22/19)
192960042S (Exp. 12/22/19)
192970034S (Exp. 12/22/19)
192970036S (Exp. 12/22/19)
192970037S (Exp. 12/22/19)
192980043S (Exp. 12/25/19)
192980044S (Exp. 12/25/19)
192980045S (Exp. 12/25/19)
193010042S (Exp. 12/26/19)
193020042S (Exp. 12/27/19)
193030039S (Exp. 12/28/19)
193030040S (Exp. 12/28/19)
193030049S (Exp. 12/28/19)
193040045S (Exp. 12/29/19)
193040046S (Exp. 12/29/19)
193040047S (Exp. 12/29/19)
193080040S (Exp. 1/2/20)
193080041S (Exp. 1/2/20)
193080042S (Exp. 1/2/20)
193080043S (Exp. 1/2/20)
193080044S (Exp. 1/2/20)
193090034S (Exp. 1/3/20)
193090035S (Exp. 1/3/20)
193090036S (Exp. 1/3/20)
193100041S (Exp. 1/4/20)
193100042S (Exp. 1/4/20)
193100043S (Exp. 1/4/20)
193120036S (Exp. 1/8/20)
193150028S (Exp. 1/9/20)
193170033S (Exp. 1/11/20)
193170034S (Exp. 1/11/20)
193170035S (Exp. 1/11/20)
193180035S (Exp. 1/12/20)
193190035S (Exp. 1/15/20)
193190038S (Exp. 1/15/20)
193220038S (Exp. 1/16/20)
193230037S (Exp. 1/17/20)
193240029S (Exp. 1/18/20)
193240030S (Exp. 1/18/20)
193240031S (Exp. 1/18/20)
193250028S (Exp. 1/19/20)
193360031S (Exp. 1/30/20)
Date Ranges: 12/18/19 - 1/30/20
Product: NORepinephrine Bitartrate 8 mg added to 500 mL 5% Dextrose Injection USP (16 mcg per mL) Total Volume 508.00 mL Viaflex Bag
Model:
D-0626-2020
Lot Numbers:
193040035S (Exp. 12/29/2019)
193120031S (Exp. 01/08/2020)
193150024S (Exp. 01/09/20)
193180030S (Exp. 01/12/20)
193240028S (Exp. 01/18/20)
193250022S (Exp. 01/19/20)
Date Ranges: 12/29/2019 - 01/19/2020
Product: NORepinephrine Bitartrate 4 mg added to 250 mL 5% Dextrose Injection USP (16 mcg per mL) Total Volume 254.00 mL Viaflex Bag
Model:
D-0627-2020
Lot Numbers:
192930026S (Exp. 12/18/19)
192950020S (Exp. 12/20/19)
192960029S (Exp. 12/21/19)
192970024S (Exp. 12/22/19)
193010034S (Exp. 12/26/19)
193030036S (Exp. 12/28/19)
193040029S (Exp. 12/29/19)
193050030S (Exp. 1/1/20)
193080025S (Exp. 1/2/20)
193080026S (Exp. 1/2/20)
193080027S (Exp. 1/2/20)
193090017S (Exp. 1/3/20)
193090018S (Exp. 1/3/20)
193100032S (Exp. 1/4/20)
193120028S (Exp. 1/8/20)
193160027S (Exp. 1/10/20)
193170024S (Exp. 1/11/20)
193170025S (Exp. 1/11/20)
193180026S (Exp. 1/12/20)
193190031S (Exp. 1/15/20)
193230027S (Exp. 1/17/20)
193240015S (Exp. 1/18/20)
193240016S (Exp. 1/18/20)
193240017S (Exp. 1/18/20)
193240018S (Exp. 1/18/20)
193250017S (Exp. 1/19/20)
Date Ranges: 12/18/19 - 1/19/20

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84525
Status: Resolved
Manufacturer: Pharmedium Services, LLC
Sold By: Hospitals; Healthcare Facilities; Authorized Medical Distributors
Manufactured In: United States
Units Affected: 3 products (5820 bags; 864 bags; 5808 bags)
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.