FDA Recalls Ethanol Injection Vials Due to Sterility Concerns
US Specialty Formulations is recalling 781 vials of Ethanol for Injection 95% due to lack of assurance of sterility. The product was distributed nationwide to medical facilities and physician offices.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a sterility assurance issue in an injectable drug, which poses a risk of harm. However, no illnesses, injuries, or hospitalizations have been reported, placing this at the 'High' severity level per the rubric's criterion for risk-of-harm products without reported injury.
Plain-English summary
US Specialty Formulations LLC is recalling 781 vials of Ethanol for Injection 95% (67 mL multi-dose vials, prescription only) due to lack of assurance of sterility. The product was manufactured by US Specialty Formulations and distributed nationwide to medical facilities and physician offices.
The recall affects vials from three lots: Lot 02RP1503A (expiration date 30-Sep-22), Lot 02RP1506A (expiration date 31-Dec-22), and Lot 02RP1516A (expiration date 30-Jun-23). The lack of assurance of sterility poses a potential risk to patients if the product is used.
Healthcare providers and physicians who received this product should immediately discontinue use of the affected lots and contact US Specialty Formulations for further instructions. Patients who may have received injections from these vials should consult their healthcare provider.
The recalled product
- Product
- Ethanol for Injection 95%, 67 mL Multi-Dose vial, Rx only, US Specialty Formulations, 1403 South Albert Street, Allentown, PA 18103, PN: 69389-06229
- Manufacturer
- US Specialty Formulations LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 781
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot #: 02RP1503A
- exp. date 30-Sep-22
- 02RP1506A
- exp. date 31-Dec-22
- 02RP1516A
- exp. date 30-Jun-23
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by US Specialty Formulations LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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