Antacid Tablets Recalled

Ultra-Tab Laboratories Inc is recalling numerous antacid products. The February 16, 2022, US Food and Drug Administration (FDA) Enforcement Report listed deviations from Current Good Manufacturing Practice regulations as the reason for the recall.

The following products, which were delivered in bulk to 3 distributors that may have further distributed the tablets, are being recalled:

• Cherry Antacid Tablets (calcium carbonate 420 mg), bulk container (NDC 62959-304-00, product code M304), from bulk lots 18K059, 18L106, 18L117, 18M067, and 18M068;
• Trial Antacid Tablets (calcium carbonate 420 mg), bulk container (NDC 62959-310-00, product code M310), from bulk lots 19C044 and 19H015;
• Peppermint Antacid Tablets (calcium carbonate 420 mg), bulk container (NDC 62959-303-00, product codes M303 and M303A), from bulk lots 19C042, 19C043, 19F083, and 19E105;
• Spearmint Antacid Tablets (calcium carbonate 420 mg), bulk container (NDC 62959-311-00, product code M311), from bulk lot 19A069; and
• Nutralox Peppermint Antacid Tablets (calcium carbonate 420 mg), bulk container (NDC 62959-312-00, product code M312), from bulk lots 18J004, 18J005, 18C045, and 19C046.

Ultra-Tab Laboratories voluntarily initiated the recall January 26, 2022. The FDA designated the recall Class II on February 9, 2022, signaling that use of the products could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Calcium carbonate antacid tablets are used to relieve heartburn, acid indigestion, and sour stomach.