Recalls / Class II
Class IID-0400-2024
Product
fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% 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 70004-0289-64, Bar Code 70004028964
- Affected lot / code info
- Lot #: 1223049261, Exp 12/25/23; 1223049724, Exp 01/11/24
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- SCA Pharmaceuticals, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 755 Rainbow Rd Ste B, N/A, Windsor, Connecticut 06095-1024
Distribution
- Quantity
- 412 cassettes
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-11-09
- FDA classified
- 2024-03-22
- Posted by FDA
- 2024-04-03
- Terminated
- 2024-08-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0400-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.