Drug product
Acetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only. Manufactured by Akron Inc., Lake Forest, IL 60045. NDC 17478-660-30.
D-0916-2018
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 80310
- Status
- Terminated
- Classification
- Class II
- Quantity
- 89,507 vials
- Official record key
drug-enforcement:D-0916-2018
Official wording
Reason: CGMP Deviations
Code information: Lots: 061496A, Exp. 06/2018; 111696A, Exp. 11/2018; 061947A, Exp. 06/2019; 091267A, Exp. 09/2019
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations