Mint Flavored Antacid Recalled for cGMP Manufacturing Deviations
Ultra Seal Corporation is recalling 1,309,800 packets of Mint Flavored Antacid (Calcium Carbonate 420mg) distributed nationwide due to cGMP deviations. The recall is voluntary and applies to specific lot numbers with expiration dates in 2022.
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, or hospitalizations associated with the product, and the hazard is manufacturing-process-related rather than involving direct contamination or inherent defect. Per the rubric, a Class II recall with no reported harm typically scores as Moderate (2).
Plain-English summary
Ultra Seal Corporation is voluntarily recalling Mint Flavored Antacid (Calcium Carbonate 420mg) 2-tablet packets manufactured for Just American Safety, Osceola, IN. The recall covers 1,309,800 packets distributed nationwide within the United States.
The recall was initiated due to cGMP (current good manufacturing practice) deviations discovered during manufacturing. Affected lots include Lot #AK9523, K9523 with expiration date 03/2022, and Lot #AK9670 with expiration date 06/2022. The product is identified by NDC 67060-303-68.
Consumers in possession of affected packets should stop using the product. The recall was initiated on January 24, 2022, and was classified as FDA Class II on January 31, 2022. The recall was terminated on October 16, 2023.
The recalled product
- Product
- Mint Flavored Antacid (Calcium Carbonate 420mg) 2 tablet packets, Mfg for Just American Safety, Osceola, IN 46561, NDC 67060-303-68
- Manufacturer
- Ultra Seal Corporation
- Category
- Drug — Antacid
- Hazard
- cgmp-deviation
- manufacturing-practice-violation
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 #: AK9523
- K9523 Exp. Date 03/2022
- AK9670
- Exp. Date 06/2022
Distribution
Distributed nationwide across the United States.
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