diphenhydrAMINE 25 mg added to 0.9% sodium chloride 50 mL in 100 mL Partial Additive Bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7089-1.

Reason: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Code information: Lot # 37-884145, 37-884154, Exp 05/03/2023; 37-885931, Exp 05/10/2023; 37-888293, Exp 05/21/2023; 37-889057, 37-889063, Exp 05/23/2023; 37-891437, Exp 06/01/2023; 37-893455, Exp 06/11/2023; 37-893788, Exp 06/12/2023; 37-894302, Exp 06/13/2023; 37-894652, Exp 06/14/2023; 37-896817, Exp 06/22/2023; 37-897263, Exp 06/26/2023

Distribution pattern: Nationwide in the USA.