Why it was recalled
Subpotent Drug
Product description
Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentration = 50 mcg/mL, Preservative Free, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor CT 06095, NDC# 70004-0200-16.
Lot numbers, UPCs & expiration codes
Lot # 1222043351, exp. date 03/29/2023 1222043387, exp. date 04/05/2023 1222043352, exp. date 04/05/2023 1222043463, exp. date 04/06/2023 1223043922, exp. date 05/04/2023
Where it was sold
Nationwide in the US.
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-0363-2023
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 24, 2023
- FDA report date
- Mar 8, 2023
- Quantity
- 2125 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SCA Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-0363-2023, exactly as published.
Show all FDA fields
- City
- Windsor
- State
- CT
- Status
- Terminated
- Country
- United States
- Event ID
- 91774
- Address
- 755 Rainbow Rd Ste B
- Code information
- Lot # 1222043351, exp. date 03/29/2023 1222043387, exp. date 04/05/2023 1222043352, exp. date 04/05/2023 1222043463, exp. date 04/06/2023 1223043922, exp. date 05/04/2023
- Postal code
- 06095-1024
- Report date
- Mar 8, 2023
- Product type
- Drugs
- Recall number
- D-0363-2023
- Classification
- Class III
- Recalling firm
- SCA Pharmaceuticals
- Product quantity
- 2125 syringes
- Termination date
- Jun 21, 2023
- Reason for recall
- Subpotent Drug
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentration = 50 mcg/mL, Preservative Free, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor CT 06095, NDC# 70004-0200-16.
- Distribution pattern
- Nationwide in the US.
- Recall initiation date
- Feb 24, 2023
- Initial firm notification
- Letter
- Center classification date
- Feb 28, 2023