Electrolyte tablet recalled over manufacturing violations
- Recall date
- October 6, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- ULTRAtab Laboratories, Inc. recalls Electrolyte tablet (Calcium 10.8mg, Potassium 40mg, Magnesium 12 mg), ULTRAtab Laboratories, Inc., Highland, NY
- Recall number
- F-0722-2022
- FDA classification
- Class II
- Brand / firm
- ULTRAtab Laboratories, Inc.
- Sold / distributed
- Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.
Why it was recalled
cGMP Deviations
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Electrolyte tablet (Calcium 10.8mg, Potassium 40mg, Magnesium 12 mg), ULTRAtab Laboratories, Inc., Highland, NY
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