FDAFDA · Food and drugs·Recall number D-0431-2019
Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy Compounding Specialist, 31818 US Hwy 19N, Palm Harbor FL 34684.
Published February 20, 2019 · Recall initiated: December 17, 2018
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 sterility assurance.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Promise Pharmacy, LLC
- Distributor
- Nationwide in the USA.
- Lot
- Lot: 11072018@10 BUD: 12/22/2018
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.