Diphenhydramine HCl Oral Solution Recalled for Manufacturing Process Deviations

Plain-English summary

Plastikon Healthcare LLC is recalling 349,100 cups of Diphenhydramine HCl Oral Solution, 25 mg/10 mL (NDC 0904-6741-72). The product was distributed nationwide in the United States for institutional use only and is packaged in 10 mL cups.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The manufacturing processes used to produce this product were not adequately controlled, which could affect product quality and safety.

The affected lot numbers are 20065A (expiration June 2022), 20068A and 20070A (July 2022), 20097A and 20098A (October 2022), 21055A (May 2023), 21083A (July 2023), 21091A (August 2023), and 21112A (October 2023).

This is an FDA Class II drug recall. No illnesses or injuries have been reported in connection with this recall.

The recalled product

Product

Diphenhydramine HCl Oral Solution, 25 mg / 10 mL, 10 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 0904-6741-72

Manufacturer

Plastikon Healthcare LLC

Category

Drug — Antihistamine / Oral Solution

Hazard

• manufacturing-deviation

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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