D-0273-2015 Class II Terminated

Recalled by Perry Drug Inc. — Overland Park, KS

Recall Details

Product Type
Drugs
Report Date
December 3, 2014
Initiation Date
November 7, 2014
Termination Date
November 3, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
20 prefilled syringes

Product Description

Tri Mix PF SYR 0.5 mL Inj., Compounded Rx, 10 each, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5036-49

Reason for Recall

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.

Distribution Pattern

Kansas and Missouri

Code Information

141021FF, 11/21/14; 141028CC, 11/28/14