Drug product
Paricalcitol Capsules, 1 mcg, packaged in 30 Capsules (5 x 6) per carton (NDC 60687-106-25); each blister card containing 6 individually blistered capsules (NDC 60687-106-95), Rx only, Distributed by: American Health Packaging, Columbus, OH, 43217.
D-0009-2017
Product summary
- Event
- Event 75335
- Status
- Terminated
- Classification
- Class III
- Quantity
- 648 cartons
- Official record key
drug-enforcement:D-0009-2017
Official wording
Reason: Failed Impurities/Degradation Specifications: This repackaged product was recalled by its manufacturer due to failed results for impurities.
Code information: Lot 154341, Exp 03/17
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications