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Class III: unlikely to cause harmTerminated

Apotex Olanzapine Recall

Olanzapine, Orally Disintegrating Tablets, 10 mg, a) 30-count bottle (NDC 60505-3276-03…

Apotex Inc. · Toronto, N/A

Risk level
Class III
Reported by FDA
May 20, 2015
Recall ID
D-1080-2015
Check your lot numberHow we source this data

Summary

Apotex recalled Olanzapine starting Apr 7, 2015. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-1080-2015 on May 20, 2015. Reason: Subpotent drug. Status: Terminated.

Why it was recalled

Subpotent drug

Product description

Olanzapine, Orally Disintegrating Tablets, 10 mg, a) 30-count bottle (NDC 60505-3276-03), b) 100-count blister (NDC 60505-3276-00), Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9

Lot numbers, UPCs & expiration codes

Lot #: a) KY2389, Exp 05/16; b) KY2388, Exp 05/16

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-1080-2015
Classification
Class III
Status
Terminated
Recall initiated
Apr 7, 2015
FDA report date
May 20, 2015
Quantity
6,467 bottles/ blister cartons
Recall type
Voluntary: Firm initiated
Recalling firm
Apotex Inc.

Original FDA data

Every field from FDA enforcement report D-1080-2015, exactly as published.

Show all FDA fields
City
Toronto
Status
Terminated
Country
Canada
Event ID
71046
Address
150 Signet Drive
Code information
Lot #: a) KY2389, Exp 05/16; b) KY2388, Exp 05/16
Report date
May 20, 2015
Product type
Drugs
Recall number
D-1080-2015
Classification
Class III
Recalling firm
Apotex Inc.
Product quantity
6,467 bottles/ blister cartons
Termination date
Apr 7, 2017
Reason for recall
Subpotent drug
Voluntary / mandated
Voluntary: Firm initiated
Product description
Olanzapine, Orally Disintegrating Tablets, 10 mg, a) 30-count bottle (NDC 60505-3276-03), b) 100-count blister (NDC 60505-3276-00), Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9
Distribution pattern
Nationwide
Recall initiation date
Apr 7, 2015
Initial firm notification
Letter
Center classification date
May 14, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1080-2015, published May 20, 2015. 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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