MIRALAC Calcium Carbonate Tablets Recalled for cGMP Deviations
Ultra Seal Corporation is recalling MIRALAC calcium carbonate 420mg tablets in mint flavor due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 409,890 packets distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: The FDA classified this as a Class II recall with no reported illnesses or injuries mentioned in the source text. The hazard is a manufacturing practice deviation without direct evidence of harm, placing it in the Moderate category per the severity rubric.
Plain-English summary
Ultra Seal Corporation is recalling MIRALAC (calcium carbonate 420mg) tablets in mint flavor, sold in 2-count packets and distributed by Honeywell Safety Products USA. The recall was initiated on January 24, 2022, due to deviations from current Good Manufacturing Practice (cGMP) standards.
The affected product is Lot #AK9486 with an expiration date of February 2022. Approximately 409,890 packets were distributed nationwide within the United States.
This is a voluntary recall initiated by the firm. The U.S. Food and Drug Administration classified this as a Class II recall on January 31, 2022. The recall was terminated on October 16, 2023.
Consumers who have purchased this product should discontinue use and may contact the manufacturer for further instructions.
The recalled product
- Product
- MIRALAC (calcium carbonate 420mg) tablets, Mint Flavor, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
- Manufacturer
- Ultra Seal Corporation
- Affected units
- 409,890
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 #: AK9486
- Exp. Date 02/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 56 recalled by Ultra Seal Corporation under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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