Recalls / Class II
Class IID-922-2015
Product
Tetracaine (free base) 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
- 15627 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-922-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.