Recalls / Class II
Class IID-0297-2020
Product
S-TRIMIX various strengths to include:a) S-TRIMIX (15MG/1MG/10MCG/ML) MDV: b) S-TRIMIX (18MG/0.6MG/6MCG/ML) MDV INJ: c) S-TRIMIX (24MG/0.89MG/8.9MCG/ML) MDV INJ: d) S-TRIMIX (28.85MG/1.9MG/19.2MCG/ML) MDV: e) S-TRIMIX (30MG/1MG/10MCG/ML) MDV: f) S-TRIMIX (30MG/2MG/25MCG/ML) MDV: g) S-TRIMIX (40MG/3MG/39MCG/ML) MDV INJ: h) S-TRIMIX (PA 60MG/PH 1.25MG/PG 6MCG/ML) MDV INJ: i) S-TRIMIX HYOCTANE (29.4MG/1MG/9MCG/ML) j) S-TRIMIX III (29.4MG/0.98MG/9.8MCG/ML) INJ: k) S-TRIMIX STD (16.67MG/0.58MG/8.88MCG/ML) INJ: l) S-TRIMIX-104 (30MG/2MG/20MCG/ML) MDV: m) S-TRIMIX-DS (16.67MG/0.58MG/17.7MCG/ML) MDV: Rx Only, 5ml glass vial. Red Mountain Compounding Rx
- Affected lot / code info
- Lot #:a) S07162019DH@07, EXP. 9/16/19 b) S06242019DH@01, EXP 8/24/19; S07102019DT@15, EXP. 9/20/19; S07252019DH@03, EXP. 9/25/19; S07312019DH@13, EXP. 9/31/19 c) S07102019DT@03, EXP. 9/10/19 d) S07262019DH@01, EXP. 9/26/19; S07232019DH@07, EXP. 9/23/19 e) S06262019DH@05, EXP. 8/26/19; S07132019DT@06, EXP. 9/13/19 f) S06162019DH@12, EXP. 8/16/19 g) S06252019DT@06, EXP. 8/25/19; S07032019DT@04, EXP. 9/3/19; S07102019DT@02, EXP. 9/10/19; h) S07172019dt@13, EXP. 9/17/19 i) S07032019DT@01, EXP. 9/3/19 j) S06092019DH@07, EXP. 8/9/19; S06112019DH@03, EXP. 8/11/19; S06122019DT@01, EXP. 8/12/19 k) S07022019DT@05, EXP. 9/2/19; S07132019DT@04, EXP. 9/13/19 l) S07022019DT@01, EXP. 9/2/19; S07302019DH@06, EXP. 9/30/19 m) S06252019DT@07, EXP. 8/25/19; n) S07022019DT@04, EXP. 9/2/19
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
- 34x5ml 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-0297-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.