Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported July 23, 2014
Hemo-Stat Solution, Aluminum chloride 25%, in 37.2 g glass bottles, distributed by Benco Dental, Pittston, PA; Also distributed by Henry Shein, Melville, NY; and Hemoban distributed by iSmile Dental Products, Sacramento, CA
Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Axcentria Pharmaceuticals, LLC recalled Hemo-Stat Solution, Aluminum chloride 25%, in 37.2 g glass bottles, distributed by Benco … - a moderate-severity action.
Hemo-Stat Solution, Aluminum chloride 25%, in 37.2 g glass bottles, distributed by Benco … was recalled by Axcentria Pharmaceuticals, LLC in July 23, 2014. Reason: Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number. Check the official notice for the remedy. Verify recall #D-1434-2014 with the FDA Drug before acting.
The recall
Axcentria Pharmaceuticals, LLC issued this moderate-severity FDA Drug recall-Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number.
- Moderate
- severity level
- Class II
- classification
- July 23, 2014
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-1434-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-1434-2014) was formally reported on July 23, 2014, with the manufacturer initiating the action on May 5, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Axcentria Pharmaceuticals, LLC is listed as the recalling firm, operating out of Telford, PA. Federal records list the affected scope as 20,369 bottles.
The documented reason for this recall is: Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number 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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
20,369 bottles
Related Recalls
6
5 from same agency
Product description
Hemo-Stat Solution, Aluminum chloride 25%, in 37.2 g glass bottles, distributed by Benco Dental, Pittston, PA; Also distributed by Henry Shein, Melville, NY; and Hemoban distributed by iSmile Dental Products, Sacramento, CA
Reason for recall
Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-1434-2014 |
| Date reported | July 23, 2014 |
| Date initiated | May 5, 2014 |
| Recalling firm | Axcentria Pharmaceuticals, LLC |
| Firm location | Telford, PA |
| Affected scope | 20,369 bottles |
| 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-1434-2014) 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.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. 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? ▼
Hemo-Stat Solution, Aluminum chloride 25%, in 37.2 g glass bottles, distributed by Benco Dental, Pittston, PA; Also distributed by Henry Shein, Melville, NY; and Hemoban distributed by iSmile Dental Products, Sacramento, CA. Recalled by Axcentria Pharmaceuticals, LLC. Units affected: 20,369 bottles.
Why was this product recalled? ▼
Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 23, 2014. Severity: Moderate. Recall number: D-1434-2014.
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-1434-2014) 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.
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Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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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 July 23, 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.