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Class III: unlikely to cause harmTerminated

Amerisource Health Services Fenofibrate Capsules Recall

Fenofibrate Capsules (Micronized), 134 mg Capsules, 20-count Unit Dose Blister Packs pe…

Amerisource Health Services · Columbus, OH

Risk level
Class III
Reported by FDA
Apr 20, 2016
Recall ID
D-0822-2016
Check your lot numberHow we source this data

Summary

Amerisource Health Services recalled Fenofibrate Capsules starting Mar 31, 2016. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0822-2016 on Apr 20, 2016. Reason: Labeling: Incorrect or Missing Lot and/or Exp Date. Status: Terminated.

Why it was recalled

Labeling: Incorrect or Missing Lot and/or Exp Date

Product description

Fenofibrate Capsules (Micronized), 134 mg Capsules, 20-count Unit Dose Blister Packs per carton, Rx Only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217, Carton of 20: NDC 68084-835-32, Individual Dose: NDC 68084-835-33.

Lot numbers, UPCs & expiration codes

Lot #144332C; Exp. 04/16 Lot #155224; Exp. 05/17

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-0822-2016
Classification
Class III
Status
Terminated
Recall initiated
Mar 31, 2016
FDA report date
Apr 20, 2016
Quantity
228 cartons ( 4,560 capsules)
Recall type
Voluntary: Firm initiated
Recalling firm
Amerisource Health Services

Original FDA data

Every field from FDA enforcement report D-0822-2016, exactly as published.

Show all FDA fields
City
Columbus
State
OH
Status
Terminated
Country
United States
Event ID
73715
Address
2550 John Glenn Ave
Address (line 2)
Suite A
Code information
Lot #144332C; Exp. 04/16 Lot #155224; Exp. 05/17
Postal code
43217-1188
Report date
Apr 20, 2016
Product type
Drugs
Recall number
D-0822-2016
Classification
Class III
Recalling firm
Amerisource Health Services
Product quantity
228 cartons ( 4,560 capsules)
Termination date
Jan 11, 2017
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date
Voluntary / mandated
Voluntary: Firm initiated
Product description
Fenofibrate Capsules (Micronized), 134 mg Capsules, 20-count Unit Dose Blister Packs per carton, Rx Only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217, Carton of 20: NDC 68084-835-32, Individual Dose: NDC 68084-835-33.
Distribution pattern
Nationwide
Recall initiation date
Mar 31, 2016
Initial firm notification
Letter
Center classification date
Apr 14, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0822-2016, published Apr 20, 2016. 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.

How we source and update recall data · Report incorrect information

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