Acetylcysteine 20% Solution — Class II drug recall D-1043-2013
Terminated recall by JCB Labs LLC, reported 2013-09-25, distributed nationwide. Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract
| Recall number | D-1043-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | JCB Labs LLC, Wichita, KS, United States |
| Recall initiated | 2013-08-23 |
| Classified | 2013-09-13 |
| Reported by FDA | 2013-09-25 |
| Terminated | 2014-08-18 |
| Distributed | Nationwide (US) |
| Quantity | 903 vials |
| Reason classes | microbial contamination, sterility |
| Expiration dates | 2013-08-26 |
Product
Acetylcysteine 20% Solution, Preservative Free, 4 mL Sterile Single Dose Vial, Not for Injection, Sterile Solution For Office Use Only, JCB Laboratories, Wichita, KS.
Reason for recall
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
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-1043-2013. 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.