Calcitriol Oral Solution 1 mcg/mL recall: Impurity Out of Spec
Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41.
Why was Calcitriol Oral Solution 1 mcg/mL recalled?
Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 360122A, EXP Date: MAY 2015
- Product
- Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41.
- Recalling firm
- Boehringer Ingelheim Roxane Inc
- Quantity
- 5364 bottles
- Distribution
- Nationwide
- Recall date
- July 16, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)