PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: February 10, 2021 Initiated: January 8, 2021 #D-0246-2021

Product Description

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.

Details

Units Affected
44,256 bottles
Distribution
Nationwide
Location
Hawthorne, NY

Frequently Asked Questions

What product was recalled?
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. Recalled by Taro Pharmaceuticals U.S.A., Inc.. Units affected: 44,256 bottles.
Why was this product recalled?
CGMP deviations.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 10, 2021. Severity: Moderate. Recall number: D-0246-2021.