Drug product
Formoterol Fumarate Dihydrate 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
D-692-2015
Product summary
- Event
- Event 70452
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 grams
- Official record key
drug-enforcement:D-692-2015
Official wording
Reason: 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.
Code information: All lots repackaged and distributed between 01/05/12 to 02/12/15
Distribution pattern: Nationwide to compounding pharmacies and research organizations.
Derived failure modes
-
Foreign material or chemical contamination
cross contamination with penicillin