Haloperidol Decanoate Injection recalled over sterility concerns
- Recall date
- April 26, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Teva Pharmaceuticals USA recalls Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals…
- Recall number
- D-0375-2021
- FDA classification
- Class II
- Brand / firm
- Teva Pharmaceuticals USA
- Sold / distributed
- Product was distributed nationwide.
Why it was recalled
Lack of Assurance of Sterility
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 00703-7121-03
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