1% LIDOCAINE HCl Injection, USP, Preservative-Free, 10 mg/mL, 30 mL Single-dose vials, packaged i...

FDA Drug Recall #D-0382-2015 — Class I — April 18, 2014

Recall Summary

Recall Number D-0382-2015
Classification Class I — Serious risk
Date Initiated April 18, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Hospira Inc.
Location Lake Forest, IL
Product Type Drugs
Quantity 120,900 vials

Product Description

1% LIDOCAINE HCl Injection, USP, Preservative-Free, 10 mg/mL, 30 mL Single-dose vials, packaged in 25-count cartons, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4279-02.

Reason for Recall

Presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, identified as iron oxide, were found embedded within the glass vial and floating in solution.

Distribution Pattern

Nationwide.

Lot / Code Information

Lot number: 31-427-DK, Exp 01JUL2015.

Other Recalls from Hospira Inc.

Recall # Classification Product Date
D-0862-2017 Class I Infant 25% DEXTROSE Injection, USP, 2.5 g (250 ... Apr 21, 2017
D-0153-2017 Class II Fentanyl Citrate Injection, USP, 100 mcg Fentan... Nov 1, 2016
D-1500-2016 Class II DOBUTamine Injection, USP 250 mg/20 mL, 20 mL V... Aug 15, 2016
D-0169-2017 Class III 5% Lidocaine HCL and 7.5% Dextrose Injection, U... Jun 29, 2016
D-1359-2016 Class II Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL)... Jun 23, 2016

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.