0.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG VIAFLEX Container, Single Dose Container, Rx...
FDA Drug Recall #D-1816-2015 — Class II — September 2, 2015
Recall Summary
| Recall Number | D-1816-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 2, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Baxter Healthcare Corporation |
| Location | Jayuya, PR |
| Product Type | Drugs |
| Quantity | 139,104 Bags |
Product Description
0.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG VIAFLEX Container, Single Dose Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38
Reason for Recall
Lack of Assurance of Sterility: Recalling firm reported a complaint for mold on the interior surface of the overpouch.
Distribution Pattern
Nationwide and Puerto Rico
Lot / Code Information
Lot #: P329821, Exp 08/31/2016
Other Recalls from Baxter Healthcare Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0296-2026 | Class II | Sterile Water for Irrigation, 250 mL, Single-Do... | Dec 22, 2025 |
| D-0596-2025 | Class II | Acetaminophen Injection 1000 mg/100 mL (10 mg/m... | Aug 20, 2025 |
| D-0039-2025 | Class II | Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL)... | Oct 30, 2024 |
| D-0649-2024 | Class I | Heparin (Heparin Sodium in 0.9% Sodium Chloride... | Aug 1, 2024 |
| D-0587-2024 | Class II | Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dial... | Jun 17, 2024 |
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.