Class I · High risk
Dextrose Injection
Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
0.9% Sodium Chloride Injection USP
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
0.9% Sodium Chloride Injection USP, 50 mL Single Dose VIAFLEX Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B1301, NDC 0338-0049-11.
Affected NDC
0338-0049-11
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Sodium Chloride NDC 00338-0049 |
9 g/1000mL | Injection, Solution Intravenous |
Baxter Healthcare Corporation | Rx |
- Recalling firm
- Baxter Healthcare Corp.
- NDC code
- 0338-0049-11
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1336-2015 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Baxter Healthcare Corp.
All 2015 recalls
Class I · High risk
0.9% Sodium Chloride Injection USP 500 mL
Presence of particulate matter: Particulates identified as fiberglass
Class II · Moderate risk
Daptomycin
CGMP Deviations
Class II · Moderate risk
Vancomycin Injection
CGMP Deviations
Other particulate / foreign matter recalls from 2015
All particulate / foreign matter recalls
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets 0.125 mg
Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet.
Class I · High risk
Dextrose Injection
Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.
Class I · High risk
0.9% Sodium Chloride Injection
Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.
Class II · Moderate risk
Baclofen USP powder
Presence of Foreign Substance
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