FDA Recall D-1354-2015
Pharmedium Services, LLC · Lake Forest, IL
Class I — life-threatening Terminated 651 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
EPINEPHrine HCl 1 mg added to 250 mL 0.9% Sodium Chloride Injection USP (4 mcg per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K6244, NDC# 61553-244-61.
Reason for recall
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.
Recall record
- Recall number
D-1354-2015- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- Nationwide
- Recall initiated
- 2015-04-13
- Classified by FDA Center
- 2015-08-25
- FDA published
- 2015-09-02
- Terminated
- 2017-01-23
- Recalling firm
- Pharmedium Services, LLC
- Firm location
- Lake Forest, IL