Why it was recalled
Failed Content Uniformity Specifications
Product description
Zemplar (paricalcitol) capsules, 1 mcg, 30-count bottle, Rx Only, Mfd for AbbVie Inc. North Chicago, IL 60064, NDC 0074-4317-30.
Lot numbers, UPCs & expiration codes
Lot #1055586, Exp.1/21/ 2018
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-0833-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 24, 2016
- FDA report date
- Apr 27, 2016
- Quantity
- 307 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AbbVie Inc.
Original FDA data
Every field from FDA enforcement report D-0833-2016, exactly as published.
Show all FDA fields
- City
- North Chicago
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 73611
- Address
- 1 N Waukegan Rd
- Code information
- Lot #1055586, Exp.1/21/ 2018
- Postal code
- 60064-1802
- Report date
- Apr 27, 2016
- Product type
- Drugs
- Recall number
- D-0833-2016
- Classification
- Class III
- Recalling firm
- AbbVie Inc.
- Product quantity
- 307 bottles
- Termination date
- Oct 20, 2016
- Reason for recall
- Failed Content Uniformity Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Zemplar (paricalcitol) capsules, 1 mcg, 30-count bottle, Rx Only, Mfd for AbbVie Inc. North Chicago, IL 60064, NDC 0074-4317-30.
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 24, 2016
- Initial firm notification
- Letter
- Center classification date
- Apr 21, 2016