Recalls / Class I
Class ID-1356-2015
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
EPINEPHrine HCl 16 mg added to 250 mL 0.9% Sodium Chloride Injection USP (64 mcg per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K6618, NDC# 61553-618-61.
- Affected lot / code info
- Lot #: 15033060S, Exp 05/03/15
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.
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
- 48 bags
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-04-13
- FDA classified
- 2015-08-25
- Posted by FDA
- 2015-09-02
- Terminated
- 2017-01-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1356-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.