5% Dextrose Injection, USP, in VIAFLEX Plastic Container Multi Pack, Rx Only, a) 50 mL (NDC 0338-...

FDA Drug Recall #D-625-2013 — Class II — May 21, 2013

Recall Summary

Recall Number D-625-2013
Classification Class II — Moderate risk
Date Initiated May 21, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Baxter Healthcare Corp.
Location Deerfield, IL
Product Type Drugs
Quantity 730,848 units

Product Description

5% Dextrose Injection, USP, in VIAFLEX Plastic Container Multi Pack, Rx Only, a) 50 mL (NDC 0338-0017-31), b) 100 mL (NDC 0338-0017-38), Baxter, Deerfield, IL 60015

Reason for Recall

Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.

Distribution Pattern

Nationwide & Puerto Rico

Lot / Code Information

Lot #: a) Product code 2B0088: P280115, P285239, Exp 7/13; b) Product code 2B0089: P280230, P280461, P285288, P285288A, P285783, Exp 8/13

Other Recalls from Baxter Healthcare Corp.

Recall # Classification Product Date
D-0852-2016 Class II Brevibloc DOUBLE STRENGTH Premixed Injection, E... Apr 12, 2016
D-0731-201 Class II 0.9% Sodium Chloride Irrigation, USP, 500 mL bo... Feb 5, 2016
D-0862-2016 Class I 0.9% Sodium Chloride Injection USP, MINI-BAG Pl... Jan 21, 2016
D-0861-2016 Class II 0.9% Sodium Chloride Injection USP, MINI-BAG Pl... Jan 21, 2016
D-0863-2016 Class I Metronidazole Injection USP, 500 mg per 100 mL ... Jan 21, 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.