Acetylcysteine Solution — Class I drug recall D-1326-2014
Terminated recall by Ben Venue Laboratories Inc, reported 2014-05-28, distributed nationwide. Presence of Particulate Matter: During a review of retain samples, the firm found a glass particulate in one l
| Recall number | D-1326-2014 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ben Venue Laboratories Inc, Bedford, OH, United States |
| Recall initiated | 2014-02-14 |
| Classified | 2014-05-19 |
| Reported by FDA | 2014-05-28 |
| Terminated | 2015-06-29 |
| Distributed | Nationwide (US) |
| Quantity | 5,131 vials |
| Reason classes | foreign material, specification failure |
| NDC | 00054-3025-02 |
Product
Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratories, Inc., Bedford, OH, NDC 0054-3025-02
Reason for recall
Presence of Particulate Matter: During a review of retain samples, the firm found a glass particulate in one lot of Acetylcysteine Solution
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-1326-2014. 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.