PlainRecalls
FDA Drug Moderate Class II Terminated

Acetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only. Manufactured by Akron Inc., Lake Forest, IL 60045. NDC 17478-660-30.

Reported: July 18, 2018 Initiated: June 22, 2018 #D-0916-2018

Product Description

Acetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only. Manufactured by Akron Inc., Lake Forest, IL 60045. NDC 17478-660-30.

Reason for Recall

CGMP Deviations

Details

Recalling Firm
Akorn, Inc.
Units Affected
89,507 vials
Distribution
U.S. Nationwide
Location
Decatur, IL

Frequently Asked Questions

What product was recalled?
Acetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only. Manufactured by Akron Inc., Lake Forest, IL 60045. NDC 17478-660-30.. Recalled by Akorn, Inc.. Units affected: 89,507 vials.
Why was this product recalled?
CGMP Deviations
Which agency issued this recall?
This recall was issued by the FDA Drug on July 18, 2018. Severity: Moderate. Recall number: D-0916-2018.