D-1101-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 15, 2022
- Initiation Date
- April 13, 2022
- Termination Date
- November 30, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 case/100 unit dose cups
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.
Reason for Recall
cGMP deviations: Temperature abuse
Distribution Pattern
USA nationwide.
Code Information
McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.