FDAFDA · Food and drugs·Recall number D-0253-2016
Glycopyrrolate USP ( 1 mg/5 mL), 5 mL Single Use syringe, For IM or IV Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3082-05
Published November 25, 2015 · Recall initiated: September 12, 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; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- US Compounding Inc
- Distributor
- Nationwide
- Lot
- Lot Numbers: 20150306@57 BUD: 11/30/2015; 20151305@40 BUD: 11/9/2015; 20151404@36 BUD: 10/11/2015; 20151603@3 BUD: 9/12/2015; 20152005@40 BUD: 11/16/2015; 20153003@10 BUD: 9/26/2015
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States