Azurity Pharmaceuticals, Inc. recalls Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle, Rx only, Mfd. for: Arbor Pharmaceuticals,…
- Recall date
- January 4, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0323-2024
- FDA classification
- Class I
- Brand / firm
- Azurity Pharmaceuticals, Inc.
- Sold / distributed
- USA nationwide
Why it was recalled
Labeling: Label Mix-up
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle, Rx only, Mfd. for: Arbor Pharmaceuticals, LLC., Atlanta, Georgia, 30328, NDC 24338-856-03
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