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Class III: unlikely to cause harmTerminated

Konsyl Pharmaceuticals Psyllium Fiber Recall

PSYLLIUM FIBER, Laxative/Supplement, 100 Capsules, OTC

Konsyl Pharmaceuticals Inc · Easton, MD

Risk level
Class III
Reported by FDA
May 21, 2014
Recall ID
D-1315-2014
Check your lot numberHow we source this data

Summary

Konsyl Pharmaceuticals recalled Psyllium Fiber starting Apr 1, 2014. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-1315-2014 on May 21, 2014. Reason: Labeling: Label Error on Declared Strength; Listed active ingredient strength is inaccurate. Status: Terminated.

Why it was recalled

Labeling: Label Error on Declared Strength; Listed active ingredient strength is inaccurate.

Product description

PSYLLIUM FIBER, Laxative/Supplement, 100 Capsules, OTC. Manufactured By: Konsyl Pharmaceuticals, Inc., Easton, MD 21601. NDC: 0224-1847-10.

Lot numbers, UPCs & expiration codes

Lot #: A44701 (expiry: 07/16) , A44701C (expiry: 07/16), J34701C-1 (expiry: 07/16)

Where it was sold

USA including FL, MN, NY, OH, OR, PA, TX, SC and Puerto Rico; Dominican Republic.

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-1315-2014
Classification
Class III
Status
Terminated
Recall initiated
Apr 1, 2014
FDA report date
May 21, 2014
Quantity
6286 Bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Konsyl Pharmaceuticals Inc

Original FDA data

Every field from FDA enforcement report D-1315-2014, exactly as published.

Show all FDA fields
City
Easton
State
MD
Status
Terminated
Country
United States
Event ID
68052
Address
8050 Industrial Park Rd
Code information
Lot #: A44701 (expiry: 07/16) , A44701C (expiry: 07/16), J34701C-1 (expiry: 07/16)
Postal code
21601-8602
Report date
May 21, 2014
Product type
Drugs
Recall number
D-1315-2014
Classification
Class III
Recalling firm
Konsyl Pharmaceuticals Inc
Product quantity
6286 Bottles
Termination date
May 26, 2016
Reason for recall
Labeling: Label Error on Declared Strength; Listed active ingredient strength is inaccurate.
Voluntary / mandated
Voluntary: Firm initiated
Product description
PSYLLIUM FIBER, Laxative/Supplement, 100 Capsules, OTC. Manufactured By: Konsyl Pharmaceuticals, Inc., Easton, MD 21601. NDC: 0224-1847-10.
Distribution pattern
USA including FL, MN, NY, OH, OR, PA, TX, SC and Puerto Rico; Dominican Republic.
Recall initiation date
Apr 1, 2014
Initial firm notification
Letter
Center classification date
May 13, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1315-2014, published May 21, 2014. 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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