Nutralox Peppermint Antacid Bulk Container Recalled for CGMP Deviations
ULTRAtab Laboratories, Inc. is recalling approximately 5.9 million tablets of Nutralox Peppermint Antacid (Calcium Carbonate 420 mg) bulk container due to Current Good Manufacturing Practice (CGMP) deviations.
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 recall is FDA Class II, and the source text does not report any illness or injury. CGMP deviations represent a manufacturing deficiency with potential but unspecified harm, consistent with a precautionary recall classification.
Plain-English summary
ULTRAtab Laboratories, Inc. of Highland, New York is recalling Nutralox Peppermint Antacid (Calcium Carbonate 420 mg) in bulk container form. The recall involves approximately 5,923,518 tablets with Product Codes M312 and Bulk Lots 18J004, 18J005, 18C045, and 19C046 (NDC 62959-312-00).
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. The bulk product was distributed to 3 distributors who may have distributed finished products to customers.
This is a voluntary recall initiated by the manufacturer on January 26, 2022, and was classified as FDA Class II on February 9, 2022. The recall was terminated on January 7, 2025. Consumers who have purchased this product should consult with their healthcare provider or pharmacist if they have questions about their use of this antacid.
The recalled product
- Product
- Nutralox Peppermint Antacid (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-312-00
- Manufacturer
- ULTRAtab Laboratories, Inc.
- Category
- Drug — Antacid
- Hazard
- cgmp-deviation
- manufacturing-deficiency
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 Codes: M312 Bulk Lots: 18J004
- 18J005
- 18C045
- 19C046
Distribution
Distribution scope not specified by the agency.
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