FDAFDA · Food and drugs·Recall number D-0201-2020
S-ATROPINE 0.01% OPHTHALMIC SOLUTION, packaged in a) 10ml and b) 50 ml dropper bottle, Rx only, Red Mountain Compounding RX.
Published November 13, 2019 · Recall initiated: August 12, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Distributor
- Nationwide in the USA
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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