Recalls / Class II
Class IID-0246-2021
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
- Brand name
- Nortriptyline Hydrochloride
- Generic name
- Nortriptyline Hydrochloride
- Active ingredient
- Nortriptyline Hydrochloride
- Route
- Oral
- NDCs
- 51672-4001, 51672-4002, 51672-4003, 51672-4004
- FDA application
- ANDA075520
- Affected lot / code info
- AC05096, AC05098, and AC05099; Exp 10/31/2022
Why it was recalled
CGMP deviations.
Recalling firm
- Firm
- Taro Pharmaceuticals U.S.A., Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Skyline Dr, Hawthorne, New York 10532-2174
Distribution
- Quantity
- 44,256 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2021-01-08
- FDA classified
- 2021-02-01
- Posted by FDA
- 2021-02-10
- Terminated
- 2023-09-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0246-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.