Recalls / Class II
Class IID-804-2015
Product
Mitotane 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
- Affected lot / code info
- All lots repackaged and distributed between 01/05/12 to 02/12/15
Why it was 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.
Recalling firm
- Firm
- Attix Pharmaceuticals
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 184 Front St E, unit 801, Toronto, N/A, Canada
Distribution
- Quantity
- 21500 grams
- Distribution pattern
- Nationwide to compounding pharmacies and research organizations.
Timeline
- Recall initiated
- 2014-11-14
- FDA classified
- 2015-04-20
- Posted by FDA
- 2015-04-29
- Terminated
- 2015-10-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-804-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.