FDAFDA · Food and drugs·Recall number D-1312-2015
SO-Acetylcysteine 10% Sterile Ophthalmic Solution, Rx Only, 10 mL bottle, Apothecary Shoppe, Compounding Pharmacy, Tulsa, OK 74135, NDC 13452-2774-94
Published August 12, 2015 · Recall initiated: June 26, 2015
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: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- The Apothecary Shoppe LLC
- Distributor
- Oklahoma
- Lot
- Lot #: 05062015@28, BUD 07/05/2015
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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