Severity
Critical
CriticalClass ITerminated
FDA Drug recall · Reported May 28, 2014
Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratories, Inc., Bedford, OH, NDC 0054-3025-02
Presence of Particulate Matter: During a review of retain samples, the firm found a glass particulate in one lot of Acetylcysteine Solution
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Ben Venue Laboratories Inc recalled Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratories, Inc., Bed… - a critical-severity action.
Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratories, Inc., Bed… was recalled by Ben Venue Laboratories Inc in May 28, 2014. Reason: Presence of Particulate Matter: During a review of retain samples, the firm found a glass particulate in one …. Check the official notice for the remedy. Verify recall #D-1326-2014 with the FDA Drug before acting.
The recall
Ben Venue Laboratories Inc issued this critical-severity FDA Drug recall-Presence of Particulate Matter: During a review of retain samples, the firm found a glass particulate in one ….
- Critical
- severity level
- Class I
- classification
- May 28, 2014
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-1326-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-1326-2014) was formally reported on May 28, 2014, with the manufacturer initiating the action on February 14, 2014. It is classified under Critical severity (Class I), with a current status of Terminated. Ben Venue Laboratories Inc is listed as the recalling firm, operating out of Bedford, OH. Federal records list the affected scope as 5,131 vials.
The documented reason for this recall is: Presence of Particulate Matter: During a review of retain samples, the firm found a glass particulate in one lot of Acetylcysteine Solution Distribution data in the federal record shows the product reached: Nationwide.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
5,131 vials
Related Recalls
6
5 from same agency
Product description
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-1326-2014 |
| Date reported | May 28, 2014 |
| Date initiated | February 14, 2014 |
| Recalling firm | Ben Venue Laboratories Inc |
| Firm location | Bedford, OH |
| Affected scope | 5,131 vials |
| Distribution | Nationwide. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-1326-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratories, Inc., Bedford, OH, NDC 0054-3025-02. Recalled by Ben Venue Laboratories Inc. Units affected: 5,131 vials.
Why was this product recalled? ▼
Presence of Particulate Matter: During a review of retain samples, the firm found a glass particulate in one lot of Acetylcysteine Solution
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 28, 2014. Severity: Critical. Recall number: D-1326-2014.
Where was the recalled product distributed? ▼
Distribution: Nationwide..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-1326-2014) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3…
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FDA Drug Moderate
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Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported May 28, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.