Recalls / Class II
Class IID-0262-2020
Product
S-ESTRADIOL CYP 5MG/ML MDV INJ IN SESAME OIL, packaged in a) 5ml, b) 10ml, c) 11ml, glass vials, Rx Only, Red Mountain Compounding RX.
- Affected lot / code info
- Lot #:S05092019DH@07, Exp 8/9/19; S05082019DT@11, Exp 8/8/19; S07032019DT@13, Exp 10/3/19; S07092019DT@09, Exp 10/9/19; S07292019DH@03, Exp 10/29/19
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
- 1x5ml, 7x10ml, 3x11ml, glass vials
- 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-0262-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.