Why it was recalled
Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number
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
Lot numbers, UPCs & expiration codes
G12069 July 2014 H12087 August 2014 H12089 August 2014 L12161 December 2014 D13076 April 2015 G13120 July 2015 I13145 September 2015 J13165 October 2015 J13166 October 2015
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1434-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 5, 2014
- FDA report date
- Jul 23, 2014
- Quantity
- 20,369 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Axcentria Pharmaceuticals, LLC
Original FDA data
Every field from FDA enforcement report D-1434-2014, exactly as published.
Show all FDA fields
- City
- Telford
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 68481
- Address
- 306 Keystone Dr
- Address (line 2)
- Unit B
- Code information
- G12069 July 2014 H12087 August 2014 H12089 August 2014 L12161 December 2014 D13076 April 2015 G13120 July 2015 I13145 September 2015 J13165 October 2015 J13166 October 2015
- Postal code
- 18969
- Report date
- Jul 23, 2014
- Product type
- Drugs
- Recall number
- D-1434-2014
- Classification
- Class II
- Recalling firm
- Axcentria Pharmaceuticals, LLC
- Product quantity
- 20,369 bottles
- Termination date
- Nov 28, 2016
- Reason for recall
- Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- May 5, 2014
- Initial firm notification
- Letter
- Center classification date
- Jul 15, 2014