5% Dextrose and 0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by...
FDA Drug Recall #D-0282-2015 — Class II — October 14, 2014
Recall Summary
| Recall Number | D-0282-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 14, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Hospira Inc. |
| Location | Lake Forest, IL |
| Product Type | Drugs |
| Quantity | 340,272 bags |
Product Description
5% Dextrose and 0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7941-09.
Reason for Recall
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Distribution Pattern
Nationwide, Puerto Rico, and U.S. Virgin Islands.
Lot / Code Information
Lot # 32-104-JT; Exp. 08/15 Lot # 34-136-JT; Exp. 10/15 Lot # 36-092-JT; Exp. 12/15
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
Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.
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.