FDAFDA · Food and drugs·Recall number D-1232-2019
Phenylephrine 40 mg in 0.9% Sodium Chloride 250 mL bag, 160 mcg/mL, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Published May 1, 2019 · Recall initiated: April 12, 2019
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
- CMC Enterprise Pharmacy
- Distributor
- NC
- Lot
- Lots: ED041912 Exp. 4/13/2019; ED051912 Exp. 4/14/2019; ED081912 Exp. 4/17/2019; ED091911 Exp. 4/18/2019; ED101912 Exp. 4/19/2019; ED111910 Exp. 4/20/2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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