FDA-Drug2022-06-15Class II
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.
Mckesson Medical-Surgical Inc. Corporate Office
Hazard
cGMP deviations: Temperature abuse
Sold states
USA nationwide.
Affected count
1 case/100 unit dose cups
Manufactured in
9954 Maryland Drive, Deep Run Iii Ste. 4000, Richmond, VA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1101-2022Don't want to check this manually?
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