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Class II: temporary or reversible health riskTerminated

Raritan Pharmaceuticals Up&Up Psyllium Fiber Supplement Recall

Up&Up Psyllium Fiber Supplement, 100% natural psyllium husk, Fiber Therapy for Regulari…

Raritan Pharmaceuticals, Inc. · East Brunswick, NJ

Risk level
Class II
Reported by FDA
Oct 31, 2012
Recall ID
D-025-2013
Check your lot numberHow we source this data

Summary

Raritan Pharmaceuticals recalled Up&Up Psyllium Fiber Supplement starting Sep 4, 2012. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-025-2013 on Oct 31, 2012. Reason: Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material. Status: Terminated.

Why it was recalled

Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.

Product description

Up&Up Psyllium Fiber Supplement, 100% natural psyllium husk, Fiber Therapy for Regularity/Fiber Supplement, 160 capsules per bottle, Distributed by: Target Corp., Minneapolis, MN 55403, Made in USA, NDC 11673-059-87, UPC 3-68163-11926-8.

Lot numbers, UPCs & expiration codes

Item 119160TGT; Lots15952, Exp 06/15; 16459, 16460, 16463, Exp 07/15; 16475, Exp 08/15

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-025-2013
Classification
Class II
Status
Terminated
Recall initiated
Sep 4, 2012
FDA report date
Oct 31, 2012
Quantity
48,120 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Raritan Pharmaceuticals, Inc.

Original FDA data

Every field from FDA enforcement report D-025-2013, exactly as published.

Show all FDA fields
City
East Brunswick
State
NJ
Status
Terminated
Country
United States
Event ID
63384
Address
8 Joanna Ct
Code information
Item 119160TGT; Lots15952, Exp 06/15; 16459, 16460, 16463, Exp 07/15; 16475, Exp 08/15
Postal code
08816-2108
Report date
Oct 31, 2012
Product type
Drugs
Recall number
D-025-2013
Classification
Class II
Recalling firm
Raritan Pharmaceuticals, Inc.
Product quantity
48,120 bottles
Termination date
Oct 7, 2014
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.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Up&Up Psyllium Fiber Supplement, 100% natural psyllium husk, Fiber Therapy for Regularity/Fiber Supplement, 160 capsules per bottle, Distributed by: Target Corp., Minneapolis, MN 55403, Made in USA, NDC 11673-059-87, UPC 3-68163-11926-8.
Distribution pattern
Nationwide
Recall initiation date
Sep 4, 2012
Initial firm notification
E-Mail
Center classification date
Oct 25, 2012

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-025-2013, published Oct 31, 2012. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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