phenylephrine 50 mg added to 0.9% sodium chloride 250 mL*, 200 mcg/mL*, 250 mL per bag, Rx only, ...
FDA Recall #D-0735-2023 — Class II — April 28, 2023
Product Description
phenylephrine 50 mg added to 0.9% sodium chloride 250 mL*, 200 mcg/mL*, 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7039-1.
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
1735 bags
Distribution
Nationwide in the USA.
Code Information
Lot # 37-887056, 37-887057, 37-887059, Exp 05/15/2023; 37-893807, Exp 06/12/2023; 37-896880, Exp 06/22/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated