FDA Recall D-1827-2015
Pharmedium Services, LLC · Lake Forest, IL
Class I — life-threatening Terminated 730 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
PHENYLephrine HCl, 60 mg added to 250 mL 0.9% Sodium Chloride Injection USP (240 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-236-50
Reason for recall
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Recall record
- Recall number
D-1827-2015- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- Nationwide
- Recall initiated
- 2015-01-28
- Classified by FDA Center
- 2015-09-23
- FDA published
- 2015-09-30
- Terminated
- 2017-01-27
- Recalling firm
- Pharmedium Services, LLC
- Firm location
- Lake Forest, IL