Recalls / Class II
Class IID-0271-2020
Product
S-METHYLCOBALAMIN 10,000MCG/ML MDV INJ; 30ML glass vial, Rx Only, Red Mountain Compounding Rx
- Affected lot / code info
- Lot #: S05162019DH@12, Exp 8/16/19; S05282019DT@06, Exp 8/28/19; S05302019DT@05, Exp 8/30/19; S06182019DT@03, Exp 9/18/19; S07102019dt@05, Exp 10/10/19; S07162019DT@08, Exp 10/16/19; S07242019DH@02, Exp 10/24/19; S07252019DH@08, Exp 10/25/19; S06242019DH@01, Exp 9/24/19; S07032019DT@10, EXP 10/03/2019, S07102019DT@05, Exp 10/10/2019, 07242019DH@02, Exp 10/24/19; S07252019DH@08, Exp 10/25/2019, S07292019DH@15, 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
- 135x30 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-0271-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.