Class I — High risk. Reasonable probability of serious harm or death.
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.
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.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Reason shortfill; reports of empty capsules.
Reason Presence of Particulate Matter: Hair was found in products
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
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