Recalls / Class II
Class IIF-1353-2014
Product
Biofilm Defense, Kirkman brand, Item # 0881-060 and 5881-060 Biofilm Defense, Pure Compounding brand, Item # 1881-060.
- Type
- Food
- Affected lot / code info
- LOT numbers: 53666006, 53666007, 53666008, 53666009,
- Quantity
- 6099 bottles (5489 bottles in US and 610 outside the US)
Why it was recalled
Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol
Recalling firm
- Firm
- Kirkman Group Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 6400 Rosewood St, Lake Oswego, Oregon 97035-5392
Distribution
- Distribution pattern
- distributed worldwide
Timeline
- Recall initiated
- 2013-11-15
- FDA classified
- 2014-01-02
- Posted by FDA
- 2014-01-08
- Terminated
- 2014-04-02
- Status
- Terminated
Source: openFDA Food Enforcement endpoint. Recall record F-1353-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings.