CLASS I Drug recall · Reported 28 May 2014 · FDA Enforcement Report
Acetylcysteine Solution, USP, 10% vial recalled
Ben Venue Laboratories is recalling Acetylcysteine Solution, USP, 10% vial, distributed nationwide in the US. The recall was initiated on 14 Feb 2014 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1326-2014
- FDA event ID
- 67512
- Recalling firm
- Ben Venue Laboratories, Bedford, OH
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 14 Feb 2014
- FDA classified
- 19 May 2014
- Reported
- 28 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 14 Feb 2014 | Recall initiated by company | |
| 19 May 2014 | Classified by FDA | +94 days |
| 28 May 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratories, Inc., Bedford, OH, NDC 0054-3025-02
Where it was distributed
Nationwide.
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: During a review of retain samples, the firm found a glass particulate in one lot of Acetylcysteine Solution
Which lots are affected?
2005479, Exp 03/14
Where was it sold?
Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ben Venue Laboratories
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | CYTARAbine for Injection USP, lyophiled in glass vials per vial recalled | Ben Venue Laboratories | Sterility | Nationwide |
| Drug | CLASS II | Leucovorin Calcium Injection USP, single use vials, 10mg/mL recalled | Ben Venue Laboratories | Particulate Matter | Nationwide |
| Drug | CLASS I | Vecuronium Bromide for Injection, For IV use only recalled | Ben Venue Laboratories | Particulate Matter | Nationwide |
| Drug | CLASS II | Midazolam HCl Injection, 5 mg/mL single use vials recalled | Ben Venue Laboratories | Packaging Defects | Nationwide |
| Drug | CLASS II | Octreotide Acetate Injection, 50 mcg/mL recalled | Ben Venue Laboratories | Packaging Defects | Nationwide |
Other Acetylcysteine recalls
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Acetylcysteine Solution, USP, 10% (100 mg/mL) recalledAcetylcysteine | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Acetylcysteine Solution, USP, 20% (200 mg/mL) recalledAcetylcysteine | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Acetylcysteine 10% Ophthalmic Solution recalled by Pharmacy Innovations | Pharmacy Innovations | Sterility | Nationwide |
| Drug | CLASS II | Acetylcysteine Ophthalmic Solution, 100mg/ml recalled | Promise Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Acetylcysteine Injection 10 mg/ (2 mg/mL) recalled by Pharm D Solutions | Pharm D Solutions | Sterility | Nationwide |