Class I · High risk
Epinephrine Injection
Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.
EPINEPHrine HCl 4 mg added to 250 mL 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: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.
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
EPINEPHrine HCl 4 mg added to 250 mL 0.9% Sodium Chloride Injection USP (16 mcg per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K6119, NDC# 61553-119-61.
Affected NDC
61553-0119-61
Compare with the code on your package — it is the most precise check available.
Drug: Epinephrine
- Recalling firm
- Pharmedium Services, LLC
- NDC code
- 61553-119-61
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1358-2015 · 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 Epinephrine recalls
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Class III · Low risk
Epinephrine Injection
Failed Impurities/Degradations Specifications
Class II · Moderate risk
EPINEPHRINE Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Maximum
Stability Data Does Not Support Expiry Date.
Class II · Moderate risk
Lidocaine HCI 2% and Epinephrine 1:100
Defective container: cracked/broken cartridges
Other recalls by Pharmedium Services, LLC
All 2015 recalls
Class II · Moderate risk
fentaNYL Citrate Injection 50 mcg per mL
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk
fentaNYL Citrate Injection
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk
ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride 5 mL syringe
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk
ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
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