FindMyRecallSubscribe
Class II: temporary or reversible health riskTerminated

The Harvard Drug Group Aripiprazole Tablets Recall

Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, Manufacture…

The Harvard Drug Group · Livonia, MI

Risk level
Class II
Reported by FDA
Dec 9, 2020
Recall ID
D-0114-2021
Check your lot numberHow we source this data

Summary

The Harvard Drug Group recalled Aripiprazole Tablets starting Nov 18, 2020. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0114-2021 on Dec 9, 2020. Reason: Failed Dissolution Specifications: Out of specification for dissolution. Status: Terminated.

Why it was recalled

Failed Dissolution Specifications: Out of specification for dissolution.

Product description

Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, Manufactured by: Apotex, Inc, Toronto, Ontario Canada M9L 1T9, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA, NDC 0904-6512-04

Lot numbers, UPCs & expiration codes

Lots: T02520, T02637, exp 02/2021

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-0114-2021
Classification
Class II
Status
Terminated
Recall initiated
Nov 18, 2020
FDA report date
Dec 9, 2020
Quantity
841 cartons
Recall type
Voluntary: Firm initiated
Recalling firm
The Harvard Drug Group

Original FDA data

Every field from FDA enforcement report D-0114-2021, exactly as published.

Show all FDA fields
City
Livonia
State
MI
Status
Terminated
Country
United States
Event ID
86787
Address
17177 N Laurel Park Dr Ste 233
Code information
Lots: T02520, T02637, exp 02/2021
Postal code
48152-3951
Report date
Dec 9, 2020
Product type
Drugs
Recall number
D-0114-2021
Classification
Class II
Recalling firm
The Harvard Drug Group
Product quantity
841 cartons
Termination date
Feb 19, 2023
Reason for recall
Failed Dissolution Specifications: Out of specification for dissolution.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, Manufactured by: Apotex, Inc, Toronto, Ontario Canada M9L 1T9, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA, NDC 0904-6512-04
Distribution pattern
Nationwide
Recall initiation date
Nov 18, 2020
Initial firm notification
Letter
Center classification date
Dec 1, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0114-2021, published Dec 9, 2020. 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.

How we source and update recall data · Report incorrect information

Other recent drug recalls