Trial Antacid Tablet bulk containers recalled for CGMP deviations
ULTRAtab Laboratories is recalling Trial Antacid Tablet bulk containers (Calcium Carbonate 420 mg) due to CGMP deviations. The product was distributed to three distributors who may have distributed finished product.
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 related to CGMP manufacturing failures in this instance, making it a precautionary or procedural issue rather than one with documented patient harm. Per the rubric, Class II recalls without reported adverse events typically score 2 (Moderate).
Plain-English summary
ULTRAtab Laboratories, Inc., located in Highland, New York, is recalling Trial Antacid Tablet bulk containers containing Calcium Carbonate 420 mg. The recall affects approximately 3,050,308 tablets (NDC 62959-310-00, Product Codes M310, Bulk Lots 19C044 and 19H015).
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The bulk product was distributed to three distributors who may have distributed finished product to consumers.
This is a voluntary recall initiated by the firm and classified as FDA Class II. The recall was initiated on January 26, 2022, and terminated on January 7, 2025.
The recalled product
- Product
- Trial Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-310-00
- 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 (2)
- Product Codes: M310 Bulk Lots: 19C044
- 19H015
Distribution
Distribution scope not specified by the agency.
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