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

FDA recall notice · announced July 18, 2018 · Akorn

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Reason for recall

CGMP Deviations

Notes

Distribution: U.S. Nationwide
Lot/code information: Lots: 061496A, Exp. 06/2018; 111696A, Exp. 11/2018; 061947A, Exp. 06/2019; 091267A, Exp. 09/2019
Quantity: 89,507 vials
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.