D-0203-2020 Class II Terminated
FDA drug recall D-0203-2020 was initiated by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy on August 12, 2019 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated April 13, 2023). Affected quantity: 1x10 ml dropper bottle.
Recall Details
- Product Type
- Drugs
- Report Date
- November 13, 2019
- Initiation Date
- August 12, 2019
- Termination Date
- April 13, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1x10 ml dropper bottle
Product Description
S-ATROPINE 0.5% OPTH SOLN, 10 ML dropper bottle, RX only, Red Mountain Compounding RX.
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: S05232019DH@04, Exp 8/23/19