Diphenhydramine Solution Recalled Due to Manufacturing Control Deviations

Plain-English summary

Plastikon Healthcare LLC is recalling Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL in pre-measured 5 mL cups due to manufacturing control deviations. The FDA determined that the product was manufactured under conditions that did not adequately control manufacturing processes, as required by Current Good Manufacturing Practice (CGMP) regulations.

The recalled product was distributed nationwide throughout the United States to institutional users. The affected lots include multiple batches with expiration dates ranging from June 2022 through October 2023, representing approximately 217,700 individual cups.

Institutional users should immediately stop using the recalled product and contact Plastikon Healthcare LLC or their distributor for return and replacement options. No illnesses or injuries related to this recall have been reported to date.

The recalled product

Product

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

Manufacturer

Plastikon Healthcare LLC

Category

Drug

Hazard

• manufacturing-control-deficiency

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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