Reported Jul 18, 2018 · Terminated

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

Akorn, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Akorn, Inc. · 1222 W Grand Ave · Decatur, IL · 62522-1412

Is this the product you have?

  • Acetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only. Manufactured by Akron Inc., Lake Forest, IL 60045. NDC 17478-660-30.
Lot codes and dates
  • Lots
    • 061496A
    • Exp. 06/2018
    • 111696A
    • Exp. 11/2018
    • 061947A
    • Exp. 06/2019
    • 091267A
    • Exp. 09/2019
Amount recalled
89,507 vials

Where it was sold

  • Nationwide

Why it was recalled

CGMP Deviations

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Nov 6, 2020 · Data as of Sep 19, 6:37 PM UTC

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