FDA recall D-0246-2021
Taro Pharmaceuticals U.S.A., Inc. · Class II · drug
Product
Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532 NDC 51672-4001-1
Reason for recall
CGMP deviations.
Distribution
Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2021-01-08
- Report date
- 2021-02-10
- Termination date
- 2023-09-07
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Hawthorne, NY, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0246-2021