oxyTOCIN 60 units added to 0.9% sodium chloride 1,000 mL per bag, Rx only, Central Admixture Phar...
FDA Recall #D-0711-2023 — Class II — April 28, 2023
Product Description
oxyTOCIN 60 units added to 0.9% sodium chloride 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6045-1.
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
1332 bags
Distribution
Nationwide in the USA.
Code Information
Lot # 37-883073, Exp 04/28/2023; 37-887776, Exp 05/17/2023; 37-889209, Exp 05/23/2023; 37-892588, Exp 06/06/2023; 37-894449, Exp 06/13/2023; 37-898552, Exp 06/29/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated