CLASS III Drug recall · Reported 14 Dec 2016 · FDA Enforcement Report
5% Lidocaine HCL and 5% Dextrose Injection, USP Single-dose ampule recalled
Hospira is recalling 5% Lidocaine HCL and 5% Dextrose Injection, USP Single-dose ampule, distributed in Puerto Rico. The recall was initiated on 29 Jun 2016 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0169-2017
- FDA event ID
- 74720
- Recalling firm
- Hospira, Lake Forest, IL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 29 Jun 2016
- FDA classified
- 6 Dec 2016
- Reported
- 14 Dec 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 29 Jun 2016 | Recall initiated by company | |
| 6 Dec 2016 | Classified by FDA | +160 days |
| 14 Dec 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
US and Puerto Rico
Questions about this recall
Is 5% Lidocaine HCL and 5% Dextrose Injection, USP Single-dose ampule recalled?
Yes. Hospira recalled 5% Lidocaine HCL and 5% Dextrose Injection, USP Single-dose ampule on 29 Jun 2016. The recall is Class III and its status is Terminated. Recall number D-0169-2017.
Why was it recalled?
Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.
Which lots are affected?
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 was it sold?
US and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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