Recalls / Class II
Class IID-0406-2024
Product
HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/ml) 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-18, Bar Code 70004030018
- Affected lot / code info
- Lot #: 1223048451 Exp 11/20/23; 1223048923 Exp 12/07/23; 1223049097 Exp 12/15/23; 1223049129 Exp 12/19/23;
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
- 1,425 syringes
- 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-0406-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.