Recalls / Class II
Class IID-0201-2020
Product
S-ATROPINE 0.01% OPHTHALMIC SOLUTION, packaged in a) 10ml and b) 50 ml dropper bottle, Rx only, Red Mountain Compounding RX.
- Affected lot / code info
- Lot #: a) S06112019DH@22, Exp 9/11/19; S06202019DT@10, Exp 9/20/19; S07312019DH@07, Exp 10/31/19; b) S07302019DH@07, Exp 10/30/19
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
- 6x10 ml, 1x50 ml dropper bottle
- 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-0201-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.