0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container bags, NDC 0338-0049-41...
FDA Drug Recall #D-1591-2014 — Class I — July 11, 2014
Recall Summary
| Recall Number | D-1591-2014 |
| Classification | Class I — Serious risk |
| Date Initiated | July 11, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Baxter Healthcare Corp. |
| Location | Deerfield, IL |
| Product Type | Drugs |
| Quantity | a) 217,536 bags; b) 161,760 bags |
Product Description
0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container bags, NDC 0338-0049-41, Product Code 2B1306; and b) 100 mL VIAFLEX Container bags, NDC 0338-0049-18, Product Code 2B1302, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.
Reason for Recall
Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
Distribution Pattern
Nationwide, Puerto Rico, Singapore, and Hong Kong
Lot / Code Information
Lot #: a) P309187, Exp 10/14; b) P298190, Exp 08/14
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
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.