Recalls / Class III
Class IIIF-1907-2013
Product
Benefibre, Orange Creme Chewables, 36ct and 100ct chewable tablet bottles. Foreign labeling: Novartis Consumer Health Canada Inc, Mississauga, ON.
- Type
- Food
- Affected lot / code info
- Lot Number and Expiration date 36ct bottle: 10101294, 12/31/2013; 10114155, 4/30/2014 100ct bottle: 10097346,8/31/2013;10104669,12/31/2013;10117018,1/31/2014;10117019, 4/30/2014;10120625,8/31/2014.
- Quantity
- 70,380 units
Why it was recalled
The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.
Recalling firm
- Firm
- Novartis Consumer Health
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 10401 Hwy 6, N/A, Lincoln, Nebraska 68517-9626
Distribution
- Distribution pattern
- Distribution was made nationwide.
Timeline
- Recall initiated
- 2013-08-06
- FDA classified
- 2013-09-19
- Posted by FDA
- 2013-09-25
- Terminated
- 2014-11-04
- Status
- Terminated
Source: openFDA Food Enforcement endpoint. Recall record F-1907-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings.