Drug recall D-1101-2022
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
Lots and codes
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.
Recall details
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA
- Quantity
- 1 case/100 unit dose cups
- Distribution
- USA nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 13, 2022
- Terminated
- November 30, 2023
Related products
- Diphenhydramine hydrochloride – drug information
- NDC 0121-0978 Diphenhydramine Hydrochloride · Diphenhydramine Hydrochloride 25 mg/10mL · PAI Holdings, LLC dba PAI Pharma
- NDC 0121-0489 Diphenhydramine Hydrochloride · Diphenhydramine Hydrochloride 12.5 mg/5mL · PAI Holdings, LLC dba PAI Pharma