FDAFDA · Food and drugs·Recall number D-0010-2017
Atropine Sulfate 0.01% in 0.9% Sodium Chloride (Ophthalmic Solution) 10 mL Total Volume in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-011-39
Published October 19, 2016 · Recall initiated: September 20, 2016
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; all compounded products within expiry produced using recalled filters
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Leiter's Compounding
- Distributor
- Nationwide
- Lot
- All unexpired lots; Expirations dates of 11/13/2016 to 01/02/2017
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States