Recalls / Class II
Class IID-1085-2020
Product
fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare Bag, in Sodium Chloride 0.9%. Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 36732 NDC 61553-113-50
- Affected lot / code info
- 193610002D, Exp 3/29/2020
Why it was recalled
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Recalling firm
- Firm
- PharMEDium Services, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 36 Stults Rd, N/A, Dayton, New Jersey 08810
Distribution
- Quantity
- 210 units
- Distribution pattern
- Distributed Nationwide in the US
Timeline
- Recall initiated
- 2020-03-16
- FDA classified
- 2020-04-06
- Posted by FDA
- 2020-04-15
- Terminated
- 2025-02-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1085-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.