FDAApril 13, 2022drug

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

cGMP deviations: Temperature abuse

What to do

FDA enforcement status: Terminated

Brands named

mckesson medical surgical inc corporate officemckessonmckesson medical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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