Spearmint Antacid Tablets Recalled for CGMP Deviations
ULTRAtab Laboratories is recalling Spearmint Antacid Tablets (Calcium Carbonate 420 mg) in bulk containers due to manufacturing process deviations. The recall affects approximately 1.5 million tablets distributed to three distributors.
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 manufacturing deviations (CGMP violations). The source text does not report any illnesses, injuries, or deaths. Class II recalls without reported harm typically warrant a Moderate severity score.
Plain-English summary
ULTRAtab Laboratories, Inc., located in Highland, New York, is voluntarily recalling Spearmint Antacid Tablets containing 420 mg Calcium Carbonate in bulk containers (NDC 62959-311-00). The recall was initiated on January 26, 2022, and classified by the FDA as a Class II recall on February 9, 2022.
The recall is due to Current Good Manufacturing Practice (CGMP) deviations identified in the manufacturing process. Approximately 1,527,203 tablets were affected, identified by product code M311 and bulk lot 19A069. The bulk product was distributed to three distributors, who may have further distributed finished product to retail customers.
Consumers and healthcare providers who have obtained this product should stop use. The recall was terminated on January 7, 2025.
The recalled product
- Product
- Spearmint Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-311-00
- Manufacturer
- ULTRAtab Laboratories, Inc.
- Category
- Drug — Antacid
- Hazard
- cgmp-deviation
- manufacturing-defect
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 (1)
- Product Codes: M311 Bulk Lots: 19A069
Distribution
Distribution scope not specified by the agency.
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