Drug product
Paricalcitol Capsules, 1 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-663-30
D-0719-2016
Product summary
- Event
- Event 72648
- Status
- Terminated
- Classification
- Class III
- Quantity
- 9,155 bottles
- Official record key
drug-enforcement:D-0719-2016
Official wording
Reason: Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
Code information: Lot #s: C404795, C404796, C404797, Exp 05/2016; C406272, C406273, C406274, C406518, Exp 07/2016; C409586, C409587, Exp 11/2016; C409588, Exp 12/2016; C501835, C501836 , C501837, Exp 02/2017; C503797, C503798, Exp 05/2017; C505009, Exp 06/2017; C505568, C505569, Exp 07/2017
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.