Recalls / Class II
Class IID-0205-2020
Product
S-BENZALKONIUM CHLORIDE 0.013% SOLUTION, 1000ml plastic container, For irrigation use only, Rx only, Red Mountain Compounding Rx.
- Affected lot / code info
- Lot #: S03142019DT@09, Exp 9/14/19; S05052019DH@04, Exp 11/5/19; S06192019DT@03, Exp 12/19/19; S06262019DT@12, Exp 12/26/19
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
- 4x1000 plastic containers
- 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-0205-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.