Magnacal Calcium Carbonate Tablets Recalled for cGMP Deviations
Ultra Seal Corporation is recalling MAGNACAL calcium carbonate 420 mg tablets (Lot #AK9768, expiration 08/2022) nationwide due to current Good Manufacturing Practice (cGMP) deviations. The voluntary recall was initiated on January 24, 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 involving cGMP (manufacturing process) deviations. The source text does not report any illnesses, injuries, or safety incidents—the hazard is procedural non-compliance rather than documented harm. Class II recalls without reported adverse events typically receive a score of 2 per the rubric.
Plain-English summary
Ultra Seal Corporation, manufacturing for Afassco Inc. of Minden, Nevada, is recalling MAGNACAL (calcium carbonate 420 mg) in 2-tablet packet form due to current Good Manufacturing Practice (cGMP) deviations. A total of 307,000 packets were distributed nationwide within the United States.
The affected product is identified by Lot #AK9768 with an expiration date of 08/2022. The recalling firm initiated this voluntary recall on January 24, 2022, notifying customers by letter. The FDA classified this as a Class II recall and terminated the recall on October 16, 2023.
Consumers in possession of affected packets should discontinue use and consult with their healthcare provider or pharmacist regarding this product.
The recalled product
- Product
- MAGNACAL (calcium carbonate 420 mg), 2 tablet packets, Manufactured for: Afassco Inc. Minden, NV 89423
- Manufacturer
- Ultra Seal Corporation
- Hazard
- cGMP-deviation
- 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 (2)
- Lot #: AK9768
- Exp. Date 08/2022
Distribution
Distributed nationwide across the United States.
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