PlainRecalls
FDA Drug Moderate Class II Terminated

Leader Fiber Capsules, 100% Natural Psyllium Fiber Laxative, Dietary Fiber Supplement, Relieves Constipation, Restores Regularity, 100 capsules per bottle, Distributed by: Cardinal Health, Dublin, OH 43017 www.myleader.com, NDC 37205-372-78, UPC 0-96295-11222-1.

Reported: October 31, 2012 Initiated: September 4, 2012 #D-024-2013

Product Description

Leader Fiber Capsules, 100% Natural Psyllium Fiber Laxative, Dietary Fiber Supplement, Relieves Constipation, Restores Regularity, 100 capsules per bottle, Distributed by: Cardinal Health, Dublin, OH 43017 www.myleader.com, NDC 37205-372-78, UPC 0-96295-11222-1.

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.

Details

Units Affected
2,988 bottles
Distribution
Nationwide
Location
East Brunswick, NJ

Frequently Asked Questions

What product was recalled?
Leader Fiber Capsules, 100% Natural Psyllium Fiber Laxative, Dietary Fiber Supplement, Relieves Constipation, Restores Regularity, 100 capsules per bottle, Distributed by: Cardinal Health, Dublin, OH 43017 www.myleader.com, NDC 37205-372-78, UPC 0-96295-11222-1.. Recalled by Raritan Pharmaceuticals, Inc.. Units affected: 2,988 bottles.
Why was this product recalled?
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 31, 2012. Severity: Moderate. Recall number: D-024-2013.