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FDAJune 7, 2022drug

Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6740-70

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

The hazard

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

What to do

FDA enforcement status: Terminated

Brands named

plastikon healthcareplastikon

Recall history

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

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Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6740-70 — Recall Details · AllClear