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Class II Recall
Central Admixture Pharmacy Services, Inc.
Product
diphenhydrAMINE 50 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 71285-7090-1.
Reason
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Classification
Class II
Status
Terminated
Lot
Lot # 37-884155, Exp 05/03/2023; 37-885992, Exp 05/10/2023; 37-887348, Exp 05/16/2023; 37-887660, Exp 05/17/2023; 37-889052, Exp 05/23/2023; 37-891155, 37-891156, Exp 05/31/2023; 37-891443, Exp 06/01/2023; 37-892475, Exp 06/06/2023
Date
2023-05-31
Disclaimer:
This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.