D-0916-2018 Class II Terminated

Recalled by Akorn, Inc. — Decatur, IL

Recall Details

Product Type
Drugs
Report Date
July 18, 2018
Initiation Date
June 22, 2018
Termination Date
November 6, 2020
Voluntary/Mandated
Product Quantity
89,507 vials

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

Distribution Pattern

U.S. Nationwide

Code Information

Lots: 061496A, Exp. 06/2018; 111696A, Exp. 11/2018; 061947A, Exp. 06/2019; 091267A, Exp. 09/2019