FDA-Drug2014-07-16Class II
Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41.
Boehringer Ingelheim Roxane Inc
Hazard
Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point
Sold states
Nationwide
Affected count
5364 bottles
Manufactured in
1809 Wilson Rd, Columbus, OH, United States
Products
Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1427-2014Don't want to check this manually?
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