FDA Drug Recalls

Recalls / Class II

Class IID-0295-2020

Product

S-TRIMIX (40MG/2.5MG/29MCG) MDV INJ; Rx Only, 5ml glass vial, Red Mountain Compounding Rx

Affected lot / code info
Lot #:S06092019DH@04, Exp 8/9/19;

Why it was recalled

Lack of Assurance of Sterility

Recalling firm

Firm
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
6828 E Brown Rd Ste 101, N/A, Mesa, Arizona 85207-3761

Distribution

Quantity
1x5 ml glass vial
Distribution pattern
Nationwide in the USA

Timeline

Recall initiated
2019-08-12
FDA classified
2019-11-05
Posted by FDA
2019-11-13
Terminated
2023-04-13
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0295-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.