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Novartis Consumer Health
FDA recall F-1907-2013 · Class III · reported 2013-09-25 · Terminated
- Product
- Benefibre, Orange Creme Chewables, 36ct and 100ct chewable tablet bottles. Foreign labeling: Novartis Consumer Health Canada Inc, Mississauga, ON.
- Reason
- The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.
- Quantity
- 70,380 units
- Distribution
- Distribution was made nationwide.
- Firm location
- NE, United States
- Initiated
- Voluntary: Firm initiated
- First notice
- Letter
- Recall started
- 2013-08-06
- Terminated
- 2014-11-04
- 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.
Source: U.S. Food and Drug Administration, openFDA Food Enforcement database (openFDA Food Enforcement, imported 2026-09). The FDA does not validate openFDA data for completeness or accuracy. This is a record of an enforcement action, not safety advice.