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Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant (acetaminophen 325 mg, Gua...

FDA Recall #D-0465-2022 — Class II — January 24, 2022

Recall #D-0465-2022 Date: January 24, 2022 Classification: Class II Status: Terminated

Product Description

Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5 mg) 2 tablets per packet, Mfg, for Respond Industries and American First Aid, Mason, OH 45040

Reason for Recall

cGMP deviations

Recalling Firm

Ultra Seal Corporation — New Paltz, NY

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

313,000 packets

Distribution

Nationwide within the United States

Code Information

Lot #: K9824, Exp. Date 09/2022

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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