Drug recall
Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratories, Inc., Bedford, OH, NDC…
FDA recall event 67512 · Class I · Ben Venue Laboratories Inc
Key facts
| Event ID | 67512 |
|---|---|
| Recall numbers | D-1326-2014 |
| Recalling firm | Ben Venue Laboratories Inc |
| Product type | Drugs |
| Products | Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratories, Inc., Bedford, OH, NDC 0054-3025-02 |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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 |
| Initiation date | Feb 14, 2014 |
| Report date | May 28, 2014 |
| Termination date | Jun 29, 2015 |
| City | Bedford |
| State | OH |
| Country | United States |
| FEI number | 1519257 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: