F-0722-2022 Class II Terminated
Recall Details
- Product Type
- Food
- Report Date
- February 16, 2022
- Initiation Date
- October 6, 2021
- Termination Date
- September 1, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26,682,419 tablets
Product Description
Electrolyte tablet (Calcium 10.8mg, Potassium 40mg, Magnesium 12 mg), ULTRAtab Laboratories, Inc., Highland, NY
Reason for Recall
cGMP Deviations
Distribution Pattern
Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.
Code Information
Product Codes: M693 Bulk Lots: 18J001, 18J002, 18J003, 18L035, 18L036, 18M013, 18M014, 19A044, 19A045, 19B042, 19B043, 19B066, 19C006, 19C007, 19E065, 19E066, 19J045, 19J046