FDAClass IIFebruary 16, 2022

Electrolyte tablet recall: CGMP Deviations

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

Why was Electrolyte tablet recalled?

cGMP Deviations

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Electrolyte tablet (Calcium 10.8mg, Potassium 40mg, Magnesium 12 mg), ULTRAtab Laboratories, Inc., Highland, NY
Recalling firm
ULTRAtab Laboratories, Inc.
Quantity
26,682,419 tablets
Distribution
Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.
Recall date
February 16, 2022
Classification
Class II
Status
Terminated
Agency
FDA (food)
Open FDA enforcement record Latest FDA food recalls