Recalls / Class III
Class IIID-0169-2017
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
- Affected lot / code info
- 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
Why it was recalled
Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.
Recalling firm
- Firm
- Hospira Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, N/A, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 287,200 2 mL ampules
- Distribution pattern
- US and Puerto Rico
Timeline
- Recall initiated
- 2016-06-29
- FDA classified
- 2016-12-06
- Posted by FDA
- 2016-12-14
- Terminated
- 2019-11-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0169-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.