Recalls / Class III
Class IIID-0833-2016
Product
Zemplar (paricalcitol) capsules, 1 mcg, 30-count bottle, Rx Only, Mfd for AbbVie Inc. North Chicago, IL 60064, NDC 0074-4317-30.
- Brand name
- Zemplar
- Generic name
- Paricalcitol
- Active ingredient
- Paricalcitol
- Route
- Oral
- NDCs
- 0074-9036, 0074-4314, 0074-4317, 0074-9037
- FDA application
- NDA021606
- Affected lot / code info
- Lot #1055586, Exp.1/21/ 2018
Why it was recalled
Failed Content Uniformity Specifications
Recalling firm
- Firm
- AbbVie Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 N Waukegan Rd, N/A, North Chicago, Illinois 60064-1802
Distribution
- Quantity
- 307 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-03-24
- FDA classified
- 2016-04-21
- Posted by FDA
- 2016-04-27
- Terminated
- 2016-10-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0833-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.