Recalls / Class II
Class IID-1427-2014
Product
Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41.
- Brand name
- Calcitriol
- Generic name
- Calcitriol
- Active ingredient
- Calcitriol
- Route
- Oral
- NDC
- 0054-3120
- FDA application
- ANDA076242
- Affected lot / code info
- Lot # 360122A, EXP Date: MAY 2015
Why it was recalled
Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point
Recalling firm
- Firm
- Boehringer Ingelheim Roxane Inc
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Type
- Voluntary: Firm initiated
- Address
- 1809 Wilson Rd, Columbus, Ohio 43228-9579
Distribution
- Quantity
- 5364 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-05-01
- FDA classified
- 2014-07-09
- Posted by FDA
- 2014-07-16
- Terminated
- 2015-04-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1427-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.