Drug product
labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Use, SCA Pharmaceuticals, Windsor, CT 06095 --- NDC 70004-0700-28, UPC 70004070028
D-0603-2018
Product summary
- Event
- Event 79265
- Status
- Terminated
- Classification
- Class III
- Quantity
- 480 syringes
- Official record key
drug-enforcement:D-0603-2018
Official wording
Reason: Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indicates a compounding date of 12/27/2018 and use-by date of 03/27/2019 instead of 12/27/2017 and use-by-date of 03/27/2018
Code information: lot 1217000213, exp 03/27/2019
Distribution pattern: GA, NE & PA
Derived failure modes
-
Labeling or packaging
Labeling; Incorrect or Missing