Recalls / Class I
Class ID-1826-2015
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
PHENYLephrine HCl, 20 mg added to 250 mL 0.9% Sodium Chloride Injection USP (80 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-156-50
- Affected lot / code info
- Lot #: 14310063S, Exp 02/04/15; 14316086S, Exp 02/10/15; 14322138S, Exp 02/16/15
Why it was recalled
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).
Recalling firm
- Firm
- Pharmedium Services, LLC
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 150 N Field Dr Ste 350, N/A, Lake Forest, Illinois 60045-2506
Distribution
- Quantity
- 84 bags
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-01-28
- FDA classified
- 2015-09-23
- Posted by FDA
- 2015-09-30
- Terminated
- 2017-01-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1826-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.