CLASS II Drug recall · Reported 18 Jul 2018 · FDA Enforcement Report
Acetylcysteine for Injection (200 mg/mL) recalled by Akorn
Akorn is recalling Acetylcysteine for Injection (200 mg/mL), distributed nationwide in the US. The recall was initiated on 22 Jun 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0916-2018
- FDA event ID
- 80310
- Recalling firm
- Akorn, Decatur, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Jun 2018
- FDA classified
- 9 Jul 2018
- Reported
- 18 Jul 2018
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Injectable & IV Drugs
Timeline
| 22 Jun 2018 | Recall initiated by company | |
| 9 Jul 2018 | Classified by FDA | +17 days |
| 18 Jul 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations
Product as listed by the FDA
Acetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only. Manufactured by Akron Inc., Lake Forest, IL 60045. NDC 17478-660-30.
Where it was distributed
U.S. Nationwide
Questions about this recall
Is Acetylcysteine for Injection (200 mg/mL) recalled?
Yes. Akorn recalled Acetylcysteine for Injection (200 mg/mL) on 22 Jun 2018. The recall is Class II and its status is Terminated. Recall number D-0916-2018.
Why was it recalled?
CGMP Deviations
Which lots are affected?
Lots: 061496A, Exp. 06/2018; 111696A, Exp. 11/2018; 061947A, Exp. 06/2019; 091267A, Exp. 09/2019
Where was it sold?
U.S. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Acetylcysteine recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Acetylcysteine Solution, USP, 10% (100 mg/mL) recalledAcetylcysteine | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Acetylcysteine Solution, USP, 20% (200 mg/mL) recalledAcetylcysteine | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Acetylcysteine Injection 10 mg/ (2 mg/mL) recalled by Pharm D Solutions | Pharm D Solutions | Sterility | Nationwide |
| Drug | CLASS I | Acetylcysteine Solution, USP, 10% vial recalled | Ben Venue Laboratories | Particulate Matter | Nationwide |
| Drug | CLASS II | Acetylcysteine Injection, all strengths recalled by FVS Holdings | FVS Holdings | Sterility | Nationwide |