Recalls / Class II
Class IID-0285-2020
Product
S-TEST CYP 200MG/ML MDV IN ETHYL OLEATE OIL, Rx only, a) 5ml, b) 10 ml, c) 13ml glass vials, Red Mountain Compounding Rx.
- Affected lot / code info
- Lot #: S02072019DT@08, EXP 9/7/19; S02132019DH@06, Exp 8/13/19; S02232019DH@06 Exp 8/23/19; S02282019DH@07 Exp 8/28/19; S02252019DH@01 Exp 8/25/19; S02122019DH@06 Exp 8/12/19; S03132019DT@02 Exp 9/13/19;03202019DT@01 Exp 9/20/19; S03282019DT@05 Exp 9/28/19 S03212019DT@01 Exp 9/21/19 S04202019DT@03 Exp 10/20/19 S0412019DT@03 Exp 10/10/19 S04102019DT@12 Exp 10/10/19 S04232019DT@02 Exp 10/23/19 S03132019DT@03 Exp 9/13/19 S04232019DT@05 Exp 10/23/19 S05072019DT@07 Exp 11/7/19 S05242019DT@04 Exp 11/24/19 S06032019DT@06 Exp 12/3/19 S06182019DH@23 Exp 12/18/19 S06182019DH@22 Exp 12/18/19; S06252019DH@15, Exp 12/25/19 S06182019DH@24 Exp 12/18/19 S06262019DH@15 Exp 12/26/19 S07032019DT@03 Exp 1/3/20 S07132019DH@02 Exp 1/13/20 S07232019DH@11 Exp /23/20 S07182019DT@09 Exp 1/18/20 S07292019DH@02 Exp 1/29/20 S07312019DH@10 Exp 1/31/20 S05072019DT@07 Exp, 9/30/19 S06182019DH@23 Exp,11/30/19
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
- 559 x 5, 10, 13 ml 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-0285-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.