January 2021 FDA Recall Nortriptyline Hydrochloride by Taro Pharmaceuticals U.s.a., Inc.
D-0246-2021 - CGMP deviations.
This Class II drug recall was voluntarily initiated by Taro Pharmaceuticals U.s.a., Inc. on January 8, 2021 for the product Nortriptyline Hydrochloride. The FDA reported the reason for recall as cgmp deviations.. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0246-2021
CGMP deviations.
01-08-2021
02-10-2021
44,256 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Taro Pharmaceuticals U.S.A., Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
09-07-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# AC05096, AC05098, and AC05099; Exp 10/31/2022
