Drug product
HYDROCORTISONE LOTION, USP, 2.5%, 2 FL OZ (59 mL) bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-7785-52.
D-0859-2017
Product summary
- Event
- Event 77210
- Status
- Terminated
- Classification
- Class III
- Quantity
- 109,620 bottles
- Official record key
drug-enforcement:D-0859-2017
Official wording
Reason: Superpotent Drug: above specification for the assay.
Code information: Lot #: 0000004961, Exp. 05/17; 0000005197, 0000005198, 0000005199, Exp. 07/17; 0000005201, 0000005202, 0000005203, 0000005204, Exp. 09/17; 0000005200, 0000007998, 0000007999, 0000007022, Exp. 12/17; 0000009176, Exp. 04/18; 0000012281, 0000012282, Exp. 12/18
Distribution pattern: Nationwide in the USA and Puerto Rico.
Derived failure modes
-
Potency or specification failure
Superpotent