Drug product
CORTISOL-MC, 10mg CAP, packaged in 30 and 90 count bottles, Rx Only, ABRAMS ROYAL pharmacy II, 4909 W Park Blvd, Suite 177, Plano, TX 75093 --- NDC 88888-0043-31
D-1231-2015
Product summary
- Event
- Event 71598
- Status
- Terminated
- Classification
- Class III
- Quantity
- 30 count: 5 Bottles; 90 count: 2 Bottles
- Official record key
drug-enforcement:D-1231-2015
Official wording
Reason: Failed Content Uniformity Specifications: Failed Uniformity of Dosage Units specifications.
Code information: Lot #: 04012015@45, Expiry: 09/28/2015
Distribution pattern: United States including: Texas
Derived failure modes
-
Potency or specification failure
Failed Content Uniformity Specifications