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

FDA recall notice · announced February 10, 2021 · Taro Pharmaceuticals U.s.a

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

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

Reason for recall

CGMP deviations.

Notes

Distribution: Nationwide
Lot/code information: AC05096, AC05098, and AC05099; Exp 10/31/2022
Quantity: 44,256 bottles
Status: Terminated
Products in this recall event:
- 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 (D-0246-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.