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Class II: temporary or reversible health riskTerminated

Taro Pharmaceuticals U.S.A. Nortriptyline HCl Capsules Recall

Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd

Taro Pharmaceuticals U.S.A., Inc. · Hawthorne, NY

Risk level
Class II
Reported by FDA
Feb 10, 2021
Recall ID
D-0246-2021
Check your lot numberHow we source this data

Summary

Taro Pharmaceuticals U.S.A. recalled Nortriptyline HCl Capsules starting Jan 8, 2021. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0246-2021 on Feb 10, 2021. Reason: CGMP deviations. Status: Terminated.

Why it was recalled

CGMP deviations.

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

Lot numbers, UPCs & expiration codes

AC05096, AC05098, and AC05099; Exp 10/31/2022

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0246-2021
Classification
Class II
Status
Terminated
Recall initiated
Jan 8, 2021
FDA report date
Feb 10, 2021
Quantity
44,256 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Taro Pharmaceuticals U.S.A., Inc.

Original FDA data

Every field from FDA enforcement report D-0246-2021, exactly as published.

Show all FDA fields
City
Hawthorne
State
NY
Status
Terminated
Country
United States
Event ID
87152
Address
3 Skyline Dr
Code information
AC05096, AC05098, and AC05099; Exp 10/31/2022
Postal code
10532-2174
Report date
Feb 10, 2021
Product type
Drugs
Recall number
D-0246-2021
Classification
Class II
Recalling firm
Taro Pharmaceuticals U.S.A., Inc.
Product quantity
44,256 bottles
Termination date
Sep 7, 2023
Reason for recall
CGMP deviations.
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide
Recall initiation date
Jan 8, 2021
Initial firm notification
Letter
Center classification date
Feb 1, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0246-2021, published Feb 10, 2021. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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