Class II · Moderate risk
Epinephrine Injection
Presence of Particulate Matter
Concentrated Sodium Chloride Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Particulate Matter: In the course of inspecting retention samples visual particles were observed.
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
CONCENTRATED SODIUM CHLORIDE INJECTION, USP, 23.4% a) 30 mL SINGLE DOSE VIAL, (NDC 0517-2930-25), b) 100 mL PHARMACY BULK PACKAGE (NDC 0517-2900-25), Rx Only, AMERICAN REGENT, INC. SHIRLEY, NY 11967.
Affected NDCs
0517-2900-25
0517-2930-25
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- Luitpold Pharmaceuticals, Inc.
- NDC code
- 0517-2930-25
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1378-2012 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. 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 Luitpold Pharmaceuticals, Inc.
All 2011 recallsOther particulate / foreign matter recalls from 2011
All particulate / foreign matter recalls
Class I · High risk
Argatroban Injection 50 mg per 50ml
A complaint was received from a hospital pharmacy on 11/10/11 for crystalline particulates in a single vial from Lot V10194. Additional small visible particles consisting of fibers were identified.
Class III · Low risk
Percocet 10/325 mg tablets
Presence of Foreign Tablets/Capsules: One bottle of Percocet 10/325 mg was found to contain a tablet of Endocet 10/25 mg, the generic form.
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