Acetylcysteine for Injection 6 g/30 mL — Class II drug recall D-0916-2018
Terminated recall by Akorn, Inc., reported 2018-07-18, distributed nationwide. CGMP Deviations
| Recall number | D-0916-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Recalling firm | Akorn, Inc., Decatur, IL, United States |
| Recall initiated | 2018-06-22 |
| Classified | 2018-07-09 |
| Reported by FDA | 2018-07-18 |
| Terminated | 2020-11-06 |
| Distributed | Nationwide (US) |
| Quantity | 89,507 vials |
| Reason classes | cgmp |
| NDC | 17478-0660-30 |
| Lot numbers | 061496A, 061947A, 091267A, 111696A |
| Expiration dates | 2018-06, 2018-11, 2019-06, 2019-09 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0916-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.