Peppermint Antacid Tablets Recalled for CGMP Deviations
ULTRAtab Laboratories is recalling Peppermint Antacid tablets (Calcium Carbonate 420 mg) in bulk containers due to current good manufacturing practice (CGMP) deviations. The recall was initiated voluntarily by the manufacturer.
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: The FDA classified this as a Class II recall, and the source text does not report any illnesses, injuries, or deaths. CGMP deviations represent a manufacturing quality issue rather than a confirmed hazard to consumers. Per the rubric, Class II recalls without reported hospitalization or significant injury are typically Moderate.
Plain-English summary
ULTRAtab Laboratories, Inc., located in Highland, New York, is recalling approximately 3.3 million Peppermint Antacid tablets (Calcium Carbonate 420 mg) in bulk containers. The product is identified as NDC 62959-303-00, with Product Code M303 (bulk lots 19C042, 19C043, 19F083) and Product Code M303A (bulk lot 19E105).
The recall was issued because the bulk product did not meet current good manufacturing practice (CGMP) standards. The bulk product was distributed to three distributors, who may have distributed the finished product to other entities.
The manufacturer initiated this recall voluntarily on January 26, 2022. The FDA classified this as a Class II recall on February 9, 2022. The recall was terminated on January 7, 2025. Consumers who have this product should contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- Peppermint Antacid tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-303-00
- Manufacturer
- ULTRAtab Laboratories, Inc.
- Hazard
- cgmp-deviation
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)
- Product Code: M303 Bulk lots: 19C042
- 19C043
- 19F083
- Product Code: M303A Bulk Lot: 19E105
Distribution
Distribution scope not specified by the agency.
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