Why it was recalled
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
Lot numbers, UPCs & expiration codes
Lot #: 02RP1503A, exp. date 30-Sep-22; 02RP1506A, exp. date 31-Dec-22; 02RP1516A, exp. date 30-Jun-23
Where it was sold
Product was distributed to medical facilities and a physician's office Nationwide in the USA.
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-0986-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 24, 2022
- FDA report date
- Jun 15, 2022
- Quantity
- 781 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- US Specialty Formulations LLC
Original FDA data
Every field from FDA enforcement report D-0986-2022, exactly as published.
Show all FDA fields
- City
- Allentown
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 90257
- Address
- 1401 S Albert St
- Code information
- Lot #: 02RP1503A, exp. date 30-Sep-22; 02RP1506A, exp. date 31-Dec-22; 02RP1516A, exp. date 30-Jun-23
- Postal code
- 18103-4141
- Report date
- Jun 15, 2022
- Product type
- Drugs
- Recall number
- D-0986-2022
- Classification
- Class II
- Recalling firm
- US Specialty Formulations LLC
- Product quantity
- 781 vials
- Termination date
- Jun 17, 2024
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Recall initiation date
- May 24, 2022
- Initial firm notification
- Letter
- Center classification date
- Jun 6, 2022