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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Norepinephrine bitartrate IV Bags Recalled for Subpotency

Agency Publication Date: February 18, 2022
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Summary

BayCare Central Pharmacy is recalling 1,157 bags of Norepinephrine bitartrate (16 mg in 250 mL NaCl 0.9%) intravenous (IV) solution. This prescription medication is being recalled because it was found to be subpotent, meaning the drug is weaker than intended. The recall affects six specific lots distributed to healthcare facilities in Florida with expiration dates of March 31, 2022.

Risk

If a patient receives a subpotent dose of norepinephrine, it may fail to adequately increase their blood pressure during a critical medical event, potentially leading to serious health consequences. No incidents or injuries have been reported to date.

What You Should Do

  1. The recalled product is Norepinephrine bitartrate 16 mg in 250 mL NaCl 0.9% IV bags produced by BayCare Central Pharmacy (Temple Terrace, FL) with expiration date 3/31/22.
  2. Identify affected units by checking the lot numbers on the IV bag labels: Nore1620220111, Nore1620220113, Nore1620220118, Nore1620220125, Nore1620220127, or Nore1620220202.
  3. Stop using the recalled product immediately.
  4. Contact the manufacturer or your distributor to arrange for the return of any remaining inventory.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Norepinephrine bitartrate 16 mg in 250 mL NaCl 0.9% IV bagsby BayCare Central Pharmacy
Variants: 16 mg in 250 mL, NaCl 0.9%, IV bags, Rx only
Lot Numbers:
Nore1620220111 (Exp 3/31/22)
Nore1620220113 (Exp 3/31/22)
Nore1620220118 (Exp 3/31/22)
Nore1620220125 (Exp 3/31/22)
Nore1620220127 (Exp 3/31/22)
Nore1620220202 (Exp 3/31/22)

Quantity: 1157 bags total.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89599
Status: Resolved
Manufacturer: BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy
Sold By: BayCare Central Pharmacy; Healthcare facilities in Florida
Manufactured In: United States
Units Affected: 1157 bags
Distributed To: Florida

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 ยท 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.