Drug product
ASCORBIC ACID PRESERVED INJECTION SOLUTION, 500 mg/mL, 30 mL Sterile Multiple-Dose Vial, RX ONLY, Compounded by: Empower Pharmacy, 5980 W Sam Houston Pkwy N Ste 300 Houston, TX 77041, NDC 72627-2405-1
D-0865-2023
Product summary
- Event
- Event 92367
- Status
- Completed
- Classification
- Class II
- Quantity
- 504 vials
- Official record key
drug-enforcement:D-0865-2023
Official wording
Reason: Mislabeling: preservative free product labeled as preserved.
Code information: Lot: 606775 BUD: 09/25/2023
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Labeling or packaging
Mislabeling