Drug product
Hydrocortisone Cream 1% MS Anti itch Cream with Intensive Healing 2 oz tubes, Distributed by: Walgreen Co. 200 Wilmot Rd. Deerfield, IL 60015, NDC 0363-0237-03
D-0426-2019
Product summary
- Event
- Event 81784
- Status
- Terminated
- Classification
- Class II
- Quantity
- 67848 units
- Official record key
drug-enforcement:D-0426-2019
Official wording
Reason: GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Code information: Lot #: 36G17, 47G17, Exp. 5/2019; 84J17, Exp. 7/2019
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
GMP Deviations
-
Potency or specification failure
Out of specification