Diphenhydramine HCl oral solution, USP, 25 mg/10 mL UD, packaged in a) 10 mL unit dose cups (NDC 0121-0978-10), b) 100-count box (NDC 0121-0978-00), Rx only, MFG: Pharmaceutical Associates Inc.
Recall Number: D-1101-2022
Firm: Mckesson Medical-Surgical Inc. Corporate Office
Classification: Class II
Status: Terminated
Report Date: 20220615
Initiation Date: 20220413
Termination Date: 20231130
Reason for Recall
cGMP deviations: Temperature abuse
Product Description
Diphenhydramine HCl oral solution, USP, 25 mg/10 mL UD, packaged in a) 10 mL unit dose cups (NDC 0121-0978-10), b) 100-count box (NDC 0121-0978-00), Rx only, MFG: Pharmaceutical Associates Inc.