Drug product
Hydrocortisone Ointment, USP 2.5%, Net Wt. 20g, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed by Perrigo, Allegan MI 49010, NDC 45802-014-02
D-0817-2018
Product summary
- Firm
- Perrigo New York
- Event
- Event 80049
- Status
- Terminated
- Classification
- Class II
- Quantity
- 571,632 tubes
- Official record key
drug-enforcement:D-0817-2018
Official wording
Reason: Failed Stability Specifications
Code information: Lot Numbers: 7AT0283V, exp. 11/18 7AT0284V, exp. 11/18 7AT0285V, exp. 11/18 7FT0460, exp. 05/19 7FT0461, exp. 05/19 7GT0465, exp. 06/19 7GT0466, exp. 06/19 7JT0390, exp. 08/19 7JT0392, exp. 08/19 7KT0588, exp. 09/19 7KT0589, exp. 09/19
Distribution pattern: US Nationwide including Puerto Rico.
Derived failure modes
-
Potency or specification failure
Failed Stability Specifications