FDAFDA · Food and drugs·Recall number D-0263-2015
Phenylephrine HCl (100 mcg/mL syr) in 0.9% NaCl 1 mg / 10 mL, 3Ml Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5230-12
Published December 3, 2014 · Recall initiated: November 7, 2014
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;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Perry Drug Inc.
- Distributor
- Kansas and Missouri
- Lot
- 141008AA, 11/8/14; 141017E, 11/17/14; 141030EE, 11/30/14
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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