PHENYLephrine added to 0.9% sodium chloride, 10 mg/250 mL* (40 mcg/mL), 250 mL per bag, Rx only, ...
FDA Recall #D-0715-2023 — Class II — April 28, 2023
Product Description
PHENYLephrine added to 0.9% sodium chloride, 10 mg/250 mL* (40 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6058-1.
Reason for Recall
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recalling Firm
Central Admixture Pharmacy Services, Inc. — Allentown, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
6407 bags
Distribution
Nationwide in the USA.
Code Information
Lot # 37-884272, Exp 05/03/2023; 37-887513, Exp 05/16/2023; 37-888083, Exp 05/18/2023; 37-889123, 37-889423, Exp 05/23/2023; 37-891563, Exp 06/01/2023; 37-892577, 37-892582, Exp 06/06/2023; 37-893248, 37-893257, Exp 06/08/2023; 37-894436, Exp 06/13/2023; 37-895805, Exp 06/19/2023; 37-898324, Exp 06/28/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated