Drug product
Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP), 1%, 300 mg/30 mL, (10 mg/mL), 30 mL Single Dose Vial, 25 Vials per Tray, Rx only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047. Vial NDC 63323-487-07, Tray NDC 63323-487-37
D-0651-2021
Product summary
- Event
- Event 88194
- Status
- Terminated
- Classification
- Class II
- Quantity
- 234,800 vials
- Official record key
drug-enforcement:D-0651-2021
Official wording
Reason: Low out of specification results for epinephrine assay.
Code information: Batch, expiry: Batch 6123435, exp 01/2022; 6124730, 6124731, exp 07/2022
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Potency or specification failure
out of specification