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FDAFDA · Food and drugs·Recall number D-0261-2015

Tri-Mix (PGE-10MCG/PAP-30MG/PT 5Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5123-09

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
141008BB, 11/8/14; 141008CC, 11/8/14; 141010G, 11/10/14; 141010J, 11/10/14; 141010K, 11/10/14; 141013GG, 11/13/14; 141015DD, 11/15/14; 141015BB, 11/15/14; 141020GG, 11/20/14; 141024HH, 11/24/14; 141024II, 11/24/14; 141024JJ, 11/24/14; 141028BB, 11/28/14; 141028CC, 11/28/14; 141031GG, 12/1/14;
Risk classification
Class II
Area (FDA)
drug
Country
United States

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