Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL...

FDA Drug Recall #D-1685-2012 — Class II — August 29, 2012

Recall Summary

Recall Number D-1685-2012
Classification Class II — Moderate risk
Date Initiated August 29, 2012
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Hospira Inc.
Location Lake Forest, IL
Product Type Drugs
Quantity 148,630 vials

Product Description

Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 50 mL Single patient infusion vial, 500 mg/50 mL (10 mg/mL), NDC 0409-4699-33; c) 100 mL Single patient infusion vial, 1 g/100 mL (10 mg/mL), NDC 0409-4699-24; Rx only, Hospira, Inc., Lake Forest, IL 60045 USA

Reason for Recall

Presence of Particulate Matter: A single visible particulate was observed and confirmed in sample bottles of the recalled lots during retain inspection.

Distribution Pattern

Nationwide

Lot / Code Information

Lot No: a) 93-857-DJ, 93-896-DJ, Exp 1SEP2012; 04-515-DJ, Exp 1APR2013; 06-802-DJ, Exp 1JUN2013; b) 01-175-DJ, Exp 1JAN2013; 04-565-DJ, Exp 1APR2013; c) 03-388-DJ, Exp 1MAR2013; The lot number may be followed by 01 or 02

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.