Product: 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.
Reason for recall: cGMP deviations: Temperature abuse
Recall initiated: 20220413
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated