Recalls / Class II
Class IID-0247-2020
Product
S-PYRIDOXINE HCL (B6) 100MG/ML MDV, Rx Only, 30ml glass vial. Red Mountain Compounding Rx.
- Affected lot / code info
- Lot #: S03072019DH@10, Exp 9/7/19; S04162019DT@18, Exp 10/16/19; S05162019DH@09, Exp 11/16/19; S05232019DT@11, Exp 11/23/19; s06182019dh@31, Exp 12/18/19; S06242019DH@14, Exp 12/24/19; S07172019DT@08, Exp 1/17/20; S07232019DH@16, Exp 1/23/20; S06242019DH@14, Exp 12/24/19
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
- 38x30 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-0247-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.