Recalls / Class II
Class IID-0303-2023
Product
MEROPENEM (a) 1000MG IN NS 250ML, (b) 2GM IN NS 100ML, (c) 500mg IN NS 125ML, antibiotic, Rx Only, use with home pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
- Affected lot / code info
- Beyond Use Date: December 24-31, 2022
Why it was recalled
Lack of sterility assurance
Recalling firm
- Firm
- Sentara Infusion Services
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 535 Independence Pkwy Ste 300, N/A, Chesapeake, Virginia 23320-5176
Distribution
- Quantity
- 91 bags
- Distribution pattern
- Dispensed to Patients Nationwide.
Timeline
- Recall initiated
- 2022-12-27
- FDA classified
- 2023-02-15
- Posted by FDA
- 2023-02-22
- Terminated
- 2026-02-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0303-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.