Melatonin ER 5 mg caplet 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 Melatonin ER 5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
- Recall number
- F-0728-2022
- 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
Melatonin ER 5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
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