Hospira Recalls Lidocaine and Dextrose Injection for Stability Failures
Hospira Inc. is recalling specific lots of 5% Lidocaine HCL and 7.5% Dextrose Injection because they failed stability specifications for color and pH.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Hospira Inc. is recalling 287,200 2 mL single-dose ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP. The affected product is packaged in 5-count boxes and is labeled for spinal anesthesia only. The recall includes specific lots with expiration dates of 10/16 and 03/17.
The recall was initiated because the recalled lots did not meet the specification for color and pH throughout their shelf life. This is classified as an FDA Class III recall, which indicates that use of or exposure to the product is not likely to cause adverse health consequences.
The product was distributed in the United States and Puerto Rico. Healthcare providers and patients should stop using the affected lots and contact Hospira Inc. for further instructions or replacement.
The recalled product
- 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
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injectable Anesthetic
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- 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
Distributed in 1 state:
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