Equate Fiber Therapy, 100% Natural Psyllium Husk Fiber, Fiber Laxative/Fiber Supplement, 160 caps...

FDA Drug Recall #D-023-2013 — Class II — September 4, 2012

Recall Summary

Recall Number D-023-2013
Classification Class II — Moderate risk
Date Initiated September 4, 2012
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Raritan Pharmaceuticals, Inc.
Location East Brunswick, NJ
Product Type Drugs
Quantity 183,141 bottles

Product Description

Equate Fiber Therapy, 100% Natural Psyllium Husk Fiber, Fiber Laxative/Fiber Supplement, 160 capsules per bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 68163-119-60, UPC 6-81131-77922-7.

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.

Distribution Pattern

Nationwide

Lot / Code Information

Item Number: 4091097; Lots 15952, 16271, 16274, 16425, Exp 06/15; 16434, 16435, 16436, 16459, 16461, 16462,16465, Exp 07/15

Other Recalls from Raritan Pharmaceuticals, Inc.

Recall # Classification Product Date
D-0232-2017 Class II CVS Health Homeopathic Infants Teething Tablets... Nov 18, 2016
D-0233-2017 Class II Kids' Relief Ear Relief Oral Liquid 0.85 fl oz.... Nov 18, 2016
D-0234-2017 Class II CVS pharmacy Kids' Ear Relief Oral Liquid 0.85 ... Nov 18, 2016
D-031-2013 Class II Premier Value Fiber Plus Calcium Supplement Cap... Sep 4, 2012
D-032-2013 Class II DRxChoice Fiber Capsules, 25 capsules per bottl... Sep 4, 2012

Frequently Asked Questions

Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.