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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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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

CAPS PHENYLephrine IV Bags Recalled for Particulate Matter

Agency Publication Date: March 11, 2025
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Summary

Central Admixture Pharmacy Services, Inc. (CAPS) is recalling 1,546 bags of PHENYLephrine (phenylephrine) added to 0.9% sodium chloride, 40 mg/250 mL (160 mcg/mL). The recall was issued because particulate matter was found in the sterile injectable medication. These compounded IV bags are prescription-only products intended for hospital and office use and were distributed nationwide.

Risk

Injecting a drug containing particulate matter can cause serious health complications, such as blood vessel blockages, inflammation, or allergic reactions, which may lead to organ damage or other life-threatening issues.

What You Should Do

  1. This recall affects PHENYLephrine (phenylephrine) added to 0.9% sodium chloride (40 mg/250 mL) IV bags sold under the CAPS brand with NDC 71285-6092-1.
  2. Check your inventory for the following lot numbers and expiration dates: Lot 37-928390 (Exp 03MAR2025), Lot 37-928796 (Exp 09MAR2025), and Lot 37-928839 (Exp 10MAR2025).
  3. Stop using the recalled product immediately.
  4. Contact the manufacturer, Central Admixture Pharmacy Services, Inc. (CAPS), or your distributor at 855-275-2270 to arrange for the return of affected product.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

📋Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: PHENYLephrine added to 0.9% sodium chloride (40 mg/250 mL)by CAPS
Variants: 40 mg/250 mL, 160 mcg/mL, Sterile injectable
Lot Numbers:
37-928390 (Exp 03MAR2025)
37-928796 (Exp 09MAR2025)
37-928839 (Exp 10MAR2025)
NDC:
71285-6092-1

Compounded drug for IV use only. Volume and concentration exclude manufacturer's overfill.

Product Images

Image 1: Label for 250 mL Excel Bag containing PHENYLephrine 40 mg added to 0.9% Sodium Chloride

Image 1: Label for 250 mL Excel Bag containing PHENYLephrine 40 mg added to 0.9% Sodium Chloride

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96307
Status: Active
Manufacturer: Central Admixture Pharmacy Services, Inc.
Sold By: Hospitals; Healthcare facilities; Wholesalers
Manufactured In: United States
Units Affected: 1546 bags
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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 · FDA Press Release · 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.