Why it was recalled
Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.
Product description
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
US and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0169-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 29, 2016
- FDA report date
- Dec 14, 2016
- Quantity
- 287,200 2 mL ampules
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-0169-2017, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 74720
- Address
- 275 N Field Dr
- 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
- Postal code
- 60045-2579
- Report date
- Dec 14, 2016
- Product type
- Drugs
- Recall number
- D-0169-2017
- Classification
- Class III
- Recalling firm
- Hospira Inc.
- Product quantity
- 287,200 2 mL ampules
- Termination date
- Nov 20, 2019
- Reason for recall
- Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- US and Puerto Rico
- Recall initiation date
- Jun 29, 2016
- Initial firm notification
- Letter
- Center classification date
- Dec 6, 2016