CAPS Phenylephrine 40 mg recalled due to visible black particulate matter, USA

United States

Central Admixture Pharmacy is recalling three lots of Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bags (NDC: 71285-6092-1) to the hospital level. The product is being recalled because CAPS was notified by their raw material supplier of the detection of visible black particulate matter in a single sealed vial of Phenylephrine Hydrochloride. The affected products were distributed across the USA.

Risk Statement: Administration of an injectable product containing particulate matter may cause local irritation or swelling as a response to the foreign material. If the particulate matter enters the blood vessels, it can travel to various organs and potentially block blood vessels in the heart, lungs, or brain, leading to serious complications such as stroke or even death.

Affected Product:
- NDC: 71285-6092-1
- Product Description: Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bag
- Lot Numbers & Expiration Dates:
Lot # 37-928390 – Exp. 03MAR2025
Lot # 37-928796 – Exp. 09MAR2025
Lot # 37-928839 – Exp. 10MAR2025
- Distribution Dates: 17 Dec 2024 / 26 Dec 2024 / 03 Jan 2025 – 08 Jan 2025
- Region Distributed: United States

CAPS drug product is packaged in 0.9% Sodium Chloride 250 mL in a 250 mL Excel Bag. The product can be identified by the sample label below, the NDC format for products compounded at Lehigh Valley is “71285-XXXX-X.” The lot number format is “37-XXXXXX.”

CAPS is informing its distributors and customers through USPS-certified mail and coordinating the return process. Consumers who have experienced any issues related to using this medication should consult their doctor or healthcare provider.

If you are experiencing symptoms after using this product it is important to report it. It can help to detect & resolve outbreaks early and prevent others from being harmed, and it enables better surveillance. If symptoms persist seek medical attention.

Company name: CAPS
Brand name: CAPS
Product recalled: Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bag
Reason of the recall: Due to visible black particulate matter
FDA Recall date: February 25, 2025

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/central-admixture-pharmacy-services-caps-issues-nationwide-recall-phenylephrine-40-mg-added-09