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Class III: unlikely to cause harmTerminated

The Harvard Drug Group Aripiprazole Tablets Recall

Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by Apotex Inc

The Harvard Drug Group · Livonia, MI

Risk level
Class III
Reported by FDA
May 10, 2017
Recall ID
D-0692-2017
Check your lot numberHow we source this data

Summary

The Harvard Drug Group recalled Aripiprazole Tablets starting Dec 27, 2016. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0692-2017 on May 10, 2017. Reason: Superpotent Drug; out of specification results for assay (manufacturer). Status: Terminated.

Why it was recalled

Superpotent Drug; out of specification results for assay (manufacturer)

Product description

Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada, Distributed by Major Pharmaceuticals, Livonia, MI NDC 0904-6509-04

Lot numbers, UPCs & expiration codes

LOT: T-00601 Exp: 04-2017

Where it was sold

Nationwide and PR

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-0692-2017
Classification
Class III
Status
Terminated
Recall initiated
Dec 27, 2016
FDA report date
May 10, 2017
Quantity
36,990 tablets
Recall type
Voluntary: Firm initiated
Recalling firm
The Harvard Drug Group

Original FDA data

Every field from FDA enforcement report D-0692-2017, exactly as published.

Show all FDA fields
City
Livonia
State
MI
Status
Terminated
Country
United States
Event ID
77105
Address
17177 N Laurel Park Dr Ste 233
Code information
LOT: T-00601 Exp: 04-2017
Postal code
48152-3951
Report date
May 10, 2017
Product type
Drugs
Recall number
D-0692-2017
Classification
Class III
Recalling firm
The Harvard Drug Group
Product quantity
36,990 tablets
Termination date
Jul 27, 2017
Reason for recall
Superpotent Drug; out of specification results for assay (manufacturer)
Voluntary / mandated
Voluntary: Firm initiated
Product description
Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada, Distributed by Major Pharmaceuticals, Livonia, MI NDC 0904-6509-04
Distribution pattern
Nationwide and PR
Recall initiation date
Dec 27, 2016
Initial firm notification
Letter
Center classification date
May 2, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0692-2017, published May 10, 2017. 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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