Recalls / Class II
Class IID-0209-2020
Product
S-CYANOCOBALAMIN 1,000 MCG/ML MDV INJ SOLN, packaged in a) 10ml and b) 30 ml glass vial, Rx Only, Red Mountain Compounding Rx.
- Affected lot / code info
- Lot #: a) S05312019DT@03, Exp 8/31/19;S06032019DT@05, Exp 9/3/19 S06122019DT@07, Exp 9/12/19; b) S05312019DT@07, Exp 8/31/19; S06122019DT@07, Exp 9/12/19;S06252019DH@11, Exp 9/25/19; S07172019DT@01, Exp 10/25/19
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
- 5x10 ml and 5x30 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-0209-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.