Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp. Date
Product description
Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0522-02
Lot numbers, UPCs & expiration codes
Lot # 10008624, 10008831; Exp. 10/16 Lot # 10009339; Exp. 02/17 Lot # 10009566,10009627; Exp. 04/17 Lot # 10010200, 20001419A, 20001426A; Exp. 10/17 Lot # 20001732A; Exp. 04/18 Lot # 20001790A, 20001791A, 20001792A; Exp. 05/18
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-0820-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 17, 2016
- FDA report date
- Apr 20, 2016
- Quantity
- 28,001 HDPE bottles (14,000,500 capsules)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Impax Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0820-2016, exactly as published.
Show all FDA fields
- City
- Hayward
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 73551
- Address
- 31153 San Antonio Street
- Code information
- Lot # 10008624, 10008831; Exp. 10/16 Lot # 10009339; Exp. 02/17 Lot # 10009566,10009627; Exp. 04/17 Lot # 10010200, 20001419A, 20001426A; Exp. 10/17 Lot # 20001732A; Exp. 04/18 Lot # 20001790A, 20001791A, 20001792A; Exp. 05/18
- Postal code
- 94544
- Report date
- Apr 20, 2016
- Product type
- Drugs
- Recall number
- D-0820-2016
- Classification
- Class III
- Recalling firm
- Impax Laboratories, Inc.
- Product quantity
- 28,001 HDPE bottles (14,000,500 capsules)
- Termination date
- Oct 27, 2016
- Reason for recall
- Labeling: Incorrect or Missing Lot and/or Exp. Date
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0522-02
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 17, 2016
- Initial firm notification
- Letter
- Center classification date
- Apr 14, 2016