Recalls / Class II
Class IID-0916-2018
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.
- Affected lot / code info
- Lots: 061496A, Exp. 06/2018; 111696A, Exp. 11/2018; 061947A, Exp. 06/2019; 091267A, Exp. 09/2019
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Akorn, Inc.
- Address
- 1222 W Grand Ave, Decatur, Illinois 62522-1412
Distribution
- Quantity
- 89,507 vials
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2018-06-22
- FDA classified
- 2018-07-09
- Posted by FDA
- 2018-07-18
- Terminated
- 2020-11-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0916-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.