Detection of foreign particulate has prompted Central Admixture Pharmacy (CAPS) to recall three lots of their Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bags. According to the FDA, the company notified hospitals and distributors of the recall on Monday.
CAPS distributed the product to hospitals throughout the United States on December 17, 2024 (for Lot # 37-928390; Expiration 03MAR2025), December 26, 2024 (for Lot # 37-928796; Expiration 09MAR2025), and January 3-8, 2025 (Lot # 37-928839; Expiration 10MAR2025). The National Drug Code for their Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bags is 71285-6092-1. Customers can locate the NDC, Lot#, and expiration date on the product label.
According to Mayo Clinic, phenylephrine is often given for treatment of surgery-induced low blood pressure. A nurse or doctor administers the medication intravenously. The recalled product must be administered by a health care professional and is only available for use in medical facilities or in a home healthcare setting.
As of February 24th, CAPS has not received any reports of injury connected to the recalled product. The company initiated the recall when their raw material supplier observed black particulate in a vial of Phenylephrine Hydrochloride from one of the recalled lots. In additional to possible skin reaction at the site of injection, administration of an intravenous drug that has been contaminated by foreign particulate could introduce the particulate into the patient’s bloodstream. Any type of foreign matter in the bloodstream could travel to the heart, brain, or lungs, causing potentially fatal blockages, or embolisms.
CAPS asks all distributors and health care facilities to complete and return the “Urgent Pharmaceutical Recall Response Form” included in the recall announcement. The company sent the announcement via certified mail.
Anyone with questions or concerns about the recall can contact CAPS at 1-844-903-6417.
Patients and health care providers can report any new adverse health events related to CAPS’ Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bags through the FDA’s MedWatch Online Voluntary Reporting Form.
If you or a loved one has suffered an injury or adverse health outcome linked to contamination issues with a drug, we urge you to get in touch with our team. It’s vital that the liable parties be held accountable for their negligence to prevent the further distribution of dangerous drugs to hospitals and health care providers in the United States. Our experienced attorneys at TruLaw are prepared to learn about your story and help you begin building a case for just compensation. Contact us today or try out our free Instant Case Evaluation ℠ to get started.