Why it was recalled
Lack of Assurance of Sterility
Product description
fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0251-64, Bar Code 70004025164
Lot numbers, UPCs & expiration codes
Lot #: 1223048722, Exp 11/29/23; 1223049096, Exp 12/15/23
Where it was sold
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-0401-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 9, 2023
- FDA report date
- Apr 3, 2024
- Quantity
- 130 cassettes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SCA Pharmaceuticals, LLC
Original FDA data
Every field from FDA enforcement report D-0401-2024, exactly as published.
Show all FDA fields
- City
- Windsor
- State
- CT
- Status
- Terminated
- Country
- United States
- Event ID
- 93456
- Address
- 755 Rainbow Rd Ste B
- Code information
- Lot #: 1223048722, Exp 11/29/23; 1223049096, Exp 12/15/23
- Postal code
- 06095-1024
- Report date
- Apr 3, 2024
- Product type
- Drugs
- Recall number
- D-0401-2024
- Classification
- Class II
- Recalling firm
- SCA Pharmaceuticals, LLC
- Product quantity
- 130 cassettes
- Termination date
- Aug 27, 2024
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0251-64, Bar Code 70004025164
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Nov 9, 2023
- Initial firm notification
- Letter
- Center classification date
- Mar 22, 2024