dilTIAZem added to 0.9% sodium chloride, 125 mg/125 mL* (1 mg/mL), 125 mL per bag, Rx only, Centr...
FDA Recall #D-0713-2023 — Class II — April 28, 2023
Product Description
dilTIAZem added to 0.9% sodium chloride, 125 mg/125 mL* (1 mg/mL), 125 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6055-1.
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
3040 bags
Distribution
Nationwide in the USA.
Code Information
Lot # 37-896374, 37-896375, Exp 05/31/2023; 37-896876, 37-896878, Exp 06/02/2023; 37-897077, 37-897078, Exp 06/05/2023; 37-900074, 37-900075, 37-900076, 37-900111, 37-900112, 37-900115, Exp 06/15/2023; 37-900328, Exp 06/16/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated