FDA Drug Recalls

Recalls / Class II

Class IID-0313-2022

Product

Morphine Sulfate in 5% Dextrose Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-452-01.

Affected lot / code info
S21293/BYJ

Why it was recalled

Lack of Assurance of Sterility

Recalling firm

Firm
SterRx, LLC
Notification channel
Press Release
Type
Voluntary: Firm initiated
Address
141 Idaho Ave, Plattsburgh, New York 12903-3987

Distribution

Quantity
40 bags
Distribution pattern
U.S.A. Nationwide

Timeline

Recall initiated
2021-11-12
FDA classified
2021-12-29
Posted by FDA
2022-01-05
Terminated
2023-12-06
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0313-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.