Recalls / Class II
Class IID-1081-2020
Product
ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 mL syringe, For IV Use Preservative Free PharMEDium 913 N. Davis Ave. Cleveland, MS NDC 71030-003-12
- Affected lot / code info
- 193500004D 3/16/2020 193510006D 3/17/2020 193530011D 3/19/2020 193570003D 3/23/2020
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
- 1075 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-1081-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.