Nutralox Mint Antacid Chewable Tablets Recalled for cGMP Deviations
Ultra Seal Corporation is recalling 1,486,050 packets of Nutralox Mint Antacid chewable tablets (calcium carbonate 420mg, 2-count packets) distributed nationwide due to current Good Manufacturing Practice (cGMP) deviations.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for cGMP deviations. The source text does not report any illnesses, injuries, hospitalizations, or actual harm; the recall is precautionary based on manufacturing compliance issues. Per the rubric, Class II recalls without reported illness or injury typically fall into the Moderate range.
Plain-English summary
Ultra Seal Corporation is voluntarily recalling Nutralox Mint Antacid (calcium carbonate 420mg) chewable tablets in 2-count packets, manufactured for HARTHealth Seattle, WA 98124. The recall affects 1,486,050 packets distributed nationwide within the United States. The affected lots are AK9566 (Expiration Date 04/2022) and AK9612 (Expiration Date 05/2022).
The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations identified during manufacturing. The FDA classified this as a Class II recall.
Consumers who have purchased this product should stop using it. For additional information or to report any adverse effects, consumers should contact the manufacturer or consult the FDA's drug recall information at https://www.fda.gov/drugs/drug-safety-and-availability/drug-recalls.
The recalled product
- Product
- Nutralox Mint Antacid (calcium carbonate 420mg) Chewable tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124
- Manufacturer
- Ultra Seal Corporation
- Hazard
- cGMP-deviations
- manufacturing-compliance
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: AK9566
- Exp. Date 04/2022
- AK9612
- Exp. Date 05/2022
Distribution
Distributed nationwide across the United States.
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