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.
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: 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
- Affected units
- 3,050,308
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.
Part of a larger recall action
This product is one of 33 recalled by ULTRAtab Laboratories, Inc. 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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