Drug product
Paricalcitol Capsules, 1 mcg, 30 tablets per Bottle, Rx Only, Manufactured By: Pharmaceutics International, Inc., Hunt Valley, MD 21031, Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7656-56.
D-0774-2016
Product summary
- Event
- Event 73346
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30,891 Bottles
- Official record key
drug-enforcement:D-0774-2016
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of specification test results for impurities during stability testing.
Code information: Lot #: 13013.009A, Exp. 02/2016
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Out of specification