Multi-event June 2018 FDA Recall Calcitriol by Validus Pharmaceuticals, Inc.

This Multi-event Class III drug recall was voluntarily initiated by Validus Pharmaceuticals, Inc. on June 15, 2018 for the product Calcitriol. The FDA reported the reason for recall as subpotency. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1170-2018 TERMINATED D-1171-2018 TERMINATED

Recall Number: D-1170-2018

Reason for Recall
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
Initiated
06-15-2018
Reported
09-05-2018
Quantity
7864 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80326
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Validus Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-22-2021
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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

Affected Packages Involved in this Recall

63304-239-30 Calcitriol
63304-239-01 Calcitriol
63304-240-01 Calcitriol
63304-241-59 Calcitriol

Recall Number: D-1171-2018

Reason for Recall
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
Initiated
06-15-2018
Reported
09-05-2018
Quantity
696 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80326
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Validus Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-22-2021
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# RV1604, Exp 09/2019