DILOTAB II Sinus Cold Relief Drug Recalled for Manufacturing Deviations

Plain-English summary

Ultra Seal Corporation is voluntarily recalling DILOTAB II Sinus and Cold Relief Non Drowsy tablets containing acetaminophen 325 mg and phenylephrine HCl 5 mg. The recall affects approximately 2,685,700 packets distributed nationwide within the United States. The recall was initiated on January 24, 2022, in response to cGMP (current good manufacturing practice) deviations identified during manufacturing.

The affected product is sold in 2-tablet packets. The recalled lots include: Lot #AK9548 (L) 106 with expiration date 04/2022; Lot #AK9647 (L)103 with expiration date 06/2022; and Lot #AK9598 with expiration date 05/2022. The distributor is ZEE Medical Distributors, LLC located in Mason, OH, and the NDC number is 42961-052-03.

Consumers in possession of the recalled product should stop using it. This is a voluntary recall initiated by the manufacturer. The FDA classified this as a Class II recall. The recall was terminated on October 16, 2023.

The recalled product

Product

DILOTAB II, SINUS AND COLD RELIEF NON DROWSY (acetaminophen 325 mg, Phenylephrine HCl 5 mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-052-03

Manufacturer

Ultra Seal Corporation

Category

Drug — Over-the-counter cold and sinus relief

Hazard

• cgmp-deviation
• 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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