N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133 — Class I drug recall D-0011-2015
Terminated recall by Unique Pharmaceutical, Ltd, reported 2014-10-15, distributed nationwide. Non-Sterility: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense.
| Recall number | D-0011-2015 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Unique Pharmaceutical, Ltd, Temple, TX, United States |
| Recall initiated | 2014-07-18 |
| Classified | 2014-10-09 |
| Reported by FDA | 2014-10-15 |
| Terminated | 2016-02-24 |
| Distributed | Nationwide (US) |
| Quantity | 3,529 vials |
| Reason classes | sterility |
| Lot numbers | 86513 |
| Expiration dates | 2014-07-23 |
Product
N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133
Reason for recall
Non-Sterility: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense.
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-0011-2015. 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.