Recalls / Class I
Class ID-723-2016
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
fentaNYL Citrate, Preservative Free, 5 mcg per mL In 0.9% Sodium Chloride, 1 mL Total Volume For IV Use, packaged in a 3 mL syringe, code 2R3479, PharMEDium.
- Affected lot / code info
- Lot #: 15002077M, Exp 04-02-2015
Why it was recalled
Subpotent Drug
Recalling firm
- Firm
- Pharmedium Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 150 N Field Dr Ste 350, Lake Forest, Illinois 60045-2506
Distribution
- Quantity
- 180 syringes
- Distribution pattern
- Nine specific hospital pharmacies in VA, IA, WI, CO, CA, PA, and OK.
Timeline
- Recall initiated
- 2015-01-13
- FDA classified
- 2016-02-18
- Posted by FDA
- 2016-02-24
- Terminated
- 2016-02-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-723-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.