Why it was recalled
Lack of assurance of sterility.
Product description
Ephedrine Sulfate, 50 mg/10 mL, 10 mL Single Use Syringe, Rx only, US Compounding Pharmacy 1270 Don's Lane Conway, AR 800-718-3588, Barcode: 62295308407
Lot numbers, UPCs & expiration codes
Lot: 20181812@2 BUD: 06/16/2019
Where it was sold
U.S.A. 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-0508-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 29, 2019
- FDA report date
- Feb 27, 2019
- Quantity
- 1686 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- US Compounding Inc
Original FDA data
Every field from FDA enforcement report D-0508-2019, exactly as published.
Show all FDA fields
- City
- Conway
- State
- AR
- Status
- Terminated
- Country
- United States
- Event ID
- 82012
- Address
- 1270 Dons Ln
- Code information
- Lot: 20181812@2 BUD: 06/16/2019
- Postal code
- 72032-4753
- Report date
- Feb 27, 2019
- Product type
- Drugs
- Recall number
- D-0508-2019
- Classification
- Class II
- Recalling firm
- US Compounding Inc
- Product quantity
- 1686 syringes
- Termination date
- Jan 24, 2020
- Reason for recall
- Lack of assurance of sterility.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ephedrine Sulfate, 50 mg/10 mL, 10 mL Single Use Syringe, Rx only, US Compounding Pharmacy 1270 Don's Lane Conway, AR 800-718-3588, Barcode: 62295308407
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Jan 29, 2019
- Initial firm notification
- Letter
- Center classification date
- Feb 15, 2019