Recalls / Class II
Class IID-1088-2020
Product
ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL syringe, For IV use, Preservative Free, PharMEDium 913 W Davis Ave Cleveland MS 38732 NDC 71030-003-09
- Affected lot / code info
- 193500012D, Exp 3/16/2020
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
- 375 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-1088-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.