Acetaminophen Oral Solution Recalled for Manufacturing Process Control Failures

Plain-English summary

Plastikon Healthcare LLC is recalling Acetaminophen Oral Solution 650 mg per 20.3 mL cup distributed nationwide in the United States. The recall is due to manufacturing process control failures, as the products were manufactured under conditions that did not adequately maintain required manufacturing controls.

Approximately 3,507,740 cups are affected by this recall. The product is packaged 10 cups per tray and 10 trays per carton, for institutional use only. Affected lot numbers include 20064A, 20066A, and others, with expiration dates ranging from June 2022 through March 2024. The product is identified by NDC number 0904-6820-76.

This is a Class II recall, indicating the FDA considers there to be potential for serious adverse health consequences, though no illnesses or injuries have been reported. Individuals who have used this product should consult their healthcare provider if they have concerns.

The recalled product

Product

Acetaminophen Oral Solution 650 mg / 20.3 mL, 20.3 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 0904-6820-76

Manufacturer

Plastikon Healthcare LLC

Category

Drug

Hazard

• manufacturing-defect

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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