Is this recall still active?

The FDA lists the recall as terminated (closed 10/07/2015). FDA has determined the recall is complete and closed it.

Checked Oct 26, 2026

Class IIDrug recallTerminated

Nilotinib active pharmaceutical ingredient recall

Recalled by Attix Pharmaceuticals of Toronto, Canada · FDA report 04/29/2015

Not an official recall notice and may be delayed. Confirm with the manufacturer or the agency.

Class: Class II; Moderate
Status: Terminated; Closed 10/07/2015
Recall started: 11/14/2014
Distribution: Nationwide

Reason for recall

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Class II: Use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

Recalled product

Product: Nilotinib active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
Lot and code info: All lots repackaged and distributed between 01/05/12 to 02/12/15
Quantity: 10 grams
Recall number: D-817-2015
Event ID: 70452
Initiated by: Voluntary: Firm initiated

Where it was distributed

Nationwide to compounding pharmacies and research organizations.

Nationwide

Recall timeline

11/14/2014Firm started the recall
04/20/2015FDA classified it as Class II
04/29/2015Published in the FDA enforcement report
10/07/2015FDA closed (terminated) the recall

All products in this recall

470 products under event 70452

Showing the first 100 of 470 products.

Frequently asked questions

Why was Nilotinib active pharmaceutical ingredient recalled?: Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
What does Class II mean?: Class II is FDA's moderate recall category: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
Where was the recalled product sold?: Nationwide to compounding pharmacies and research organizations.
Is this recall still active?: The FDA lists the recall as terminated (closed 10/07/2015). FDA has determined the recall is complete and closed it.

Source: U.S. Food and Drug Administration, openFDA enforcement report · Last updated 04/29/2015 · Do not rely on openFDA to make decisions regarding medical care

Recall at a glance

Class: Class II
Status: Terminated
Type: Drug
Reported: 04/29/2015

FDA enforcement report search

What recall classes mean

Class IMost serious: A reasonable chance that using or being exposed to the product will cause serious health problems or death.
Class IIModerate: Use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
Class IIILow risk: Use of or exposure to the product is not likely to cause adverse health consequences.

Classes are assigned by the FDA based on the health hazard.

If you have a recalled product

Stop using or eating it. Check the lot number, UPC or date code against the recall.
Return it to the store or follow the firm's instructions for a refund, repair or disposal.
For medicines, talk to your pharmacist or doctor before stopping a prescription.
Report problems to the FDA through MedWatch or to the CPSC at SaferProducts.gov.

Browse recalls

About this data

Recalls: Recall information comes from NHTSA, FDA, USDA, CPSC and other agencies. A product, vehicle or lot may be affected even if it is not listed here, and listings may be delayed. Check the official recall notice and contact the manufacturer or dealer to confirm whether your item is included.

DatenUS is a private website and is not affiliated with or endorsed by any government agency. We republish public data from the sources listed on this page. Data can be incomplete, delayed or wrong. Always check the original source before you make a decision.

Our servers read this data automatically from government sources. Errors can come from the source itself or from the way we read, process or display it, and we do not guarantee that it is accurate, complete or current. Verify anything important with the official source.

Report an error Read the full disclaimer