Drug product
labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0700-28, Bar Code 70004070028
D-0411-2024
Product summary
- Event
- Event 93456
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,458, syringes
- Official record key
drug-enforcement:D-0411-2024
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 1223047334 Exp 12/23/23; 1223048170 Exp 02/01/24
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility