Rocaltrol recall
Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL, 15 mL bottle, Rx only, Distributed by: Validus Pharmaceuticals, LLC Parsippany, NJ 07054 USA, NDC 30698-911-15
Why was Rocaltrol recalled?
Subpotency: lower than expected potency result was obtained at the 18 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?
RV1604, Exp 09/2019
- Product
- Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL, 15 mL bottle, Rx only, Distributed by: Validus Pharmaceuticals, LLC Parsippany, NJ 07054 USA, NDC 30698-911-15
- Recalling firm
- Validus Pharmaceuticals, Inc.
- Quantity
- 696 bottles
- Distribution
- U.S. nationwide
- Recall date
- September 5, 2018
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)