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Class II: temporary or reversible health riskTerminated

Raritan Pharmaceuticals CVS Pharmacy Fiber Capsules for Regularity Recall

CVS Pharmacy Fiber Capsules for Regularity, Dietary Fiber Supplement, 100 Capsules per…

Raritan Pharmaceuticals, Inc. · East Brunswick, NJ

Risk level
Class II
Reported by FDA
Oct 31, 2012
Recall ID
D-022-2013
Check your lot numberHow we source this data

Summary

Raritan Pharmaceuticals recalled CVS Pharmacy Fiber Capsules for Regularity starting Sep 4, 2012. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-022-2013 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

CVS Pharmacy Fiber Capsules for Regularity, Dietary Fiber Supplement, 100 Capsules per bottle, Distributed by: CVS Pharmacy, Inc., Woonsocket, RI 02895 www.cvs.com UPC 0-50428-07739-9

Lot numbers, UPCs & expiration codes

Lots 16273, 16274, Exp 06/15; 16463, Exp 07/15

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-022-2013
Classification
Class II
Status
Terminated
Recall initiated
Sep 4, 2012
FDA report date
Oct 31, 2012
Quantity
16,848 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Raritan Pharmaceuticals, Inc.

Original FDA data

Every field from FDA enforcement report D-022-2013, 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
Lots 16273, 16274, Exp 06/15; 16463, Exp 07/15
Postal code
08816-2108
Report date
Oct 31, 2012
Product type
Drugs
Recall number
D-022-2013
Classification
Class II
Recalling firm
Raritan Pharmaceuticals, Inc.
Product quantity
16,848 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
CVS Pharmacy Fiber Capsules for Regularity, Dietary Fiber Supplement, 100 Capsules per bottle, Distributed by: CVS Pharmacy, Inc., Woonsocket, RI 02895 www.cvs.com UPC 0-50428-07739-9
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-022-2013, 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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