Berkley & Jensen Fiber Capsules, Fiber Laxative/Fiber Supplement, 100% Natural Psyllium Fiber, 40...
FDA Recall #D-028-2013 — Class II — September 4, 2012
Product Description
Berkley & Jensen Fiber Capsules, Fiber Laxative/Fiber Supplement, 100% Natural Psyllium Fiber, 400 capsules per bottle, Distributed by: BJWC, 25 Research Drive, Westborough, MA 01581, Made in USA, UPC 4-00016-27053-2.
Reason for Recall
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
Recalling Firm
Raritan Pharmaceuticals, Inc. — East Brunswick, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
3,552 bottles
Distribution
Nationwide
Code Information
Lot 16470, Exp 08/15
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated