US Specialty Formulations LLC: Drug Recall
Recall #D-0986-2022 · 05/24/2022
Class II: Risk
Recall Details
- Recall Number
- D-0986-2022
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- US Specialty Formulations LLC
- Status
- Terminated
- Date Initiated
- 05/24/2022
- Location
- Allentown, PA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 781 vials
Reason for Recall
Lack of Assurance of Sterility
Product Description
Ethanol for Injection 95%, 67 mL Multi-Dose vial, Rx only, US Specialty Formulations, 1403 South Albert Street, Allentown, PA 18103, PN: 69389-06229
Distribution Pattern
Product was distributed to medical facilities and a physician's office Nationwide in the USA.
Other Recalls by US Specialty Formulations LLC
- Class II: Risk 05/24/2022
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.