Drug product
Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by: VersaPharm Incorporated, Marietta, GA 30062; Manufactured by: Ei LLC, Kannapolis, NC 28083, NDC 61748-220-60.
D-0617-2018
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 79466
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4,128 bottles
- Official record key
drug-enforcement:D-0617-2018
Official wording
Reason: Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Code information: Lot# 2062900, Exp 05/18
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Potency or specification failure
out of specification