D-1170-2018 Class III Terminated
FDA drug recall D-1170-2018 was initiated by Validus Pharmaceuticals, Inc. on June 15, 2018 and is designated Class III. Reason for recall: Subpotency: lower than expected potency result was obtained at the 18 month stability time point. The recall status is terminated (terminated January 22, 2021). Affected quantity: 7864 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- September 5, 2018
- Initiation Date
- June 15, 2018
- Termination Date
- January 22, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7864 bottles
Product Description
Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA, NDC 63304-241-59
Reason for Recall
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
Distribution Pattern
U.S. nationwide
Code Information
RV1602RB, Exp 07/2019; RV1604RB, Exp 9/2019; RV1605RB, Exp 10/2019