FDAFDA · Food and drugs·Recall number D-1077-2023
PHENYLephrine in 0.9 sodium chloride, 800 mcg /10 mL, (80 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6008-1
Published August 9, 2023 · Recall initiated: July 17, 2023
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: Lack of validation data for sanitization cycles
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Central Admixture Pharmacy Services Inc
- Distributor
- Nationwide in the USA
- Lot
- Lot: 17-270678, 17-270695, Exp. 7/18/2023; 17-270880, Exp. 7/20/2023; 17-271075, Exp. 7/24/2023; 17-271233, 17-271269, Exp. 7/26/2023; 17-271492, 17-271494, Exp. 7/31/2023; 17-271748, Exp. 8/3/2023; 17-271891, Exp. 8/7/2023; 17-271945, Exp. 8/8/2023; 17-272221, 17-272236, Exp. 8/13/2023; 17-272286, 17-272305, Exp. 8/14/2023; 17-272642, Exp. 8/20/2023; 17-272997, 17-272998, Exp. 8/24/2023; 17-273478, 17-273496, 17-273497, Exp. 9/4/2023; 17-274139, 17-274156, 17-274163, Exp. 9/13/2023.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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