FDAClass IIISeptember 5, 2018

Calcitriol Oral Solution recall

Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA, NDC 63304-241-59

Why was Calcitriol Oral Solution 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?

RV1602RB, Exp 07/2019; RV1604RB, Exp 9/2019; RV1605RB, Exp 10/2019

Product
Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA, NDC 63304-241-59
Recalling firm
Validus Pharmaceuticals, Inc.
Quantity
7864 bottles
Distribution
U.S. nationwide
Recall date
September 5, 2018
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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