Recalls / Class II
Class IID-0240-2020
Product
S-METHYLCOBALAMIN 1,000MCG/ML MDV INJ; a) 10ml, b) 30 ml glass vial, Rx Only, Red mountain Compounding RX
- Affected lot / code info
- Lot #: a) S05162019DH@10, EXP 08/16/2019,S05242019DT@07, EXP 8/24/19, S07182019DT@14 EXP 10/18/19, b) S05162019DH@18, Exp 8/16/19;S07102019DT@04, EXP 10/10/19,S07262019DH@10 EXP 10/26/19, S07292019DH@10 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
- 60x 10 and 30 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-0240-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.