# Major Recall Alert: Phenylephrine 40 mg Added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bag Recalled Due to Visible Black Particulate Matter
**FOR IMMEDIATE RELEASE – February 24, 2025**
Central Admixture Pharmacy Services (CAPS) has announced a nationwide recall of three lots of *Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bags* due to visible black particulate matter in a raw material vial. This recall affects hospital-grade products distributed across the United States. Read on for important details regarding this recall and steps you can take to stay safe.
## Why This Recall is Important
**What’s the Concern?**
The presence of visible black particulate matter in injectable drugs is a serious safety issue. When administered, particulate matter can lead to potential medical complications:
- **Local irritation or swelling** caused by the foreign material.
- **Severe risks** if the particulate enters the bloodstream, including:
- Blockage of blood vessels in critical organs like the lungs, heart, and brain.
- Life-threatening complications, including **stroke** or even **death**.
Fortunately, as of now, CAPS has reported no injuries or adverse events related to this recall. However, healthcare providers must take immediate action to remove the affected product from circulation to prevent risks.
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## Details of the Recall
Here is everything you need to know about the affected product and recall process:
- **Product Name:** Phenylephrine 40 mg added to 0.9% Sodium Chloride in 250 mL Excel Bag
- **NDC Code:** 71285-6092-1
- **Packaging:** 250 mL Excel Bags
- **Lot Number Format:** 37-XXXXXX
- **Reason for Recall:** Detection of visible black particulate matter in a sealed raw material vial provided by CAPS’ raw material supplier.
- **Recall Scope:** Nationwide, affecting hospitals and healthcare facilities.
- **Initiation Date:** February 24, 2025
### CAPS Safety Measures
CAPS is actively notifying distributors and customers by USPS certified mail. To report inventory and return affected products, healthcare facilities must complete the **Urgent Pharmaceutical Recall Response Form** within two weeks of receiving the notification.
Forms can be submitted via:
- **Fax:** (610) 849-1197
- **Email:** recalls@bbraunusa.com
For detailed information, visit the official FDA [recall page](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/central-admixture-pharmacy-services-caps-issues-nationwide-recall-phenylephrine-40-mg-added-09).
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## What You Should Do
If your healthcare facility has stocked these products, take the following steps immediately:
- Stop using the recalled product.
- Inform appropriate personnel in your organization about the recall.
- Contact CAPS at **1-844-903-6417** for further assistance.
For patients:
- If you believe you’ve been affected by this product, contact your healthcare provider or physician.
- Report any adverse reactions to the **FDA’s MedWatch Adverse Event Reporting Program**:
- **Online:** [MedWatch](https://www.accessdata.fda.gov/scripts/medwatch/index.cfm)
- **Phone:** Call 1-800-FDA-1088 for further guidance.
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## Stay Safe – Get Instant Recall Alerts
Medical recalls often happen without public knowledge, especially with hospital-only products like this one. Protect your family and healthcare team by staying informed.
👉 **Download the MyRecalls App today** to get **real-time alerts** about recalls that may affect your health and safety. Be the first to know, and take action fast when seconds matter!
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**Final Note:** CAPS and the FDA urge all affected facilities to promptly respond to this recall to minimize potential risks. For more information, visit the [official FDA recall page](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/central-admixture-pharmacy-services-caps-issues-nationwide-recall-phenylephrine-40-mg-added-09).
Stay informed, stay safe!