Drug product
PARICALCITOL Capsules, 4 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7658-56.
D-0111-2017
Product summary
- Event
- Event 75300
- Status
- Terminated
- Classification
- Class III
- Quantity
- 5,398 bottles
- Official record key
drug-enforcement:D-0111-2017
Official wording
Reason: Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
Code information: Lot #: 13010.006A, Exp 09/16; 13010.007A, Exp 05/17
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
out of specification