Drug product
5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Single-dose ampule, 5 count box, Rx Only, For Spinal Anesthesia Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4712-01
D-0169-2017
Product summary
- Firm
- Hospira Inc.
- Event
- Event 74720
- Status
- Terminated
- Classification
- Class III
- Quantity
- 287,200 2 mL ampules
- Official record key
drug-enforcement:D-0169-2017
Official wording
Reason: Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.
Code information: Lot # 34-547-DK, 34-548-DK, Exp. 10/16, Lot # 39-372-DK, Exp. 03/17 Lot Number may be followed by numbers from 01 to 99
Distribution pattern: US and Puerto Rico
Derived failure modes
-
Potency or specification failure
Failed Stability Specifications