Recalls / Class II
Class IID-0088-2017
Product
remifentanil HCl, 50 mcg per mL, 100 mcg per 2 mL, in 0.9% Sodium Chloride, Preservative Free, 2 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3300.
- Affected lot / code info
- Lot Numbers: 151680012C, 151720013C, 151730179M, 151740029M, 151790014C, 151880319M, 151890297M, 151890318M, 151900127M, 151930081M, Exp between 07/15/15-10/12/15
Why it was recalled
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
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
- 1623 syringes
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-07-17
- FDA classified
- 2016-10-12
- Posted by FDA
- 2016-10-19
- Terminated
- 2017-06-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0088-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.