Drug product
Lidocaine HCl 1% - Phenylephrine HCl 1.5% in Sterile Water for Injection (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-002-35
D-0014-2017
Product summary
- Event
- Event 75230
- Status
- Terminated
- Classification
- Class II
- Quantity
- 76,315 total units, all products
- Official record key
drug-enforcement:D-0014-2017
Official wording
Reason: Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Code information: All unexpired lots; Expirations dates of 10/03/2016 to 12/19/2016
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility