Terminated Class II

ULTRAtab Laboratories, Inc.

Recall F-0722-2022 · Highland, NY

Product

Electrolyte tablet (Calcium 10.8mg, Potassium 40mg, Magnesium 12 mg), ULTRAtab Laboratories, Inc., Highland, NY

Reason for recall

cGMP Deviations

Distribution

Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.

Quantity affected

26,682,419 tablets

Recall type

Voluntary: Firm initiated

Lot / code info

Product Codes: M693 Bulk Lots: 18J001, 18J002, 18J003, 18L035, 18L036, 18M013, 18M014, 19A044, 19A045, 19B042, 19B043, 19B066, 19C006, 19C007, 19E065, 19E066, 19J045, 19J046

Timeline

6 Oct 2021 initiated → 9 Feb 2022 classified → 16 Feb 2022 reported → 1 Sep 2022 terminated

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