Recalls / Class II
Class IID-0593-2021
Product
HALOPERIDOL TABLETS 20mg, USP, 100-count bottle, Rx Only Distributed by: Usher-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC: 0832-1560-11
- Brand name
- Haloperidol
- Generic name
- Haloperidol
- Active ingredient
- Haloperidol
- Route
- Oral
- NDCs
- 0832-1510, 0832-1520, 0832-1530, 0832-1540, 0832-1550, 0832-1560
- FDA application
- ANDA211061
- Affected lot / code info
- 2007346C
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recalling firm
- Firm
- Cardinal Health Inc.
- Manufacturer
- Upsher-Smith Laboratories, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, N/A, Dublin, Ohio 43017-1091
Distribution
- Quantity
- 35 BOTTLE
- Distribution pattern
- FL, GA, SC
Timeline
- Recall initiated
- 2021-03-15
- FDA classified
- 2021-05-24
- Posted by FDA
- 2021-06-02
- Terminated
- 2024-06-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0593-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.