Home / Recalls / Perry Drug Inc. / D-0263-2015

D-0263-2015 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: 8 prefilled syringes

Product Description

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

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

141008AA, 11/8/14; 141017E, 11/17/14; 141030EE, 11/30/14

Other recalls by Perry Drug Inc.

D-0267-2015 Class II — HCG Low Dose 10 IU / 0.1 mL, 5 Ml vials, Compounded Rx, Perry Drug Compounding P (November 7, 2014)
D-0264-2015 Class II — Testosterone Cyp 200 mg/mL Sesame Inj., 4Ml Syringes, Compounded Rx, Perry Drug (November 7, 2014)
D-0269-2015 Class II — HCG 10,000 U/ 10 mL PF Inj, 8Ml vials, Compounded Rx, Perry Drug Compounding Pha (November 7, 2014)
D-0274-2015 Class II — HCG - 10,000 Unit PF Inject, 1mL Syringe, Compounded Rx, Perry Drug Compounding (November 7, 2014)
D-0275-2015 Class II — Sodium Tetradecyl SO4 0.3% Inj., 30 Ml vials, Compounded Rx, Perry Drug Compound (November 7, 2014)
D-0262-2015 Class II — Leuprolide 50 mcg/0.1 mL Micro Lupron Kit, 5Ml, Compounded Rx, Perry Drug Compou (November 7, 2014)
D-0272-2015 Class II — HCG-20,000 U/2 mL Vial, Compounded Rx, Perry Drug Compounding Pharmacy, Overland (November 7, 2014)
D-0265-2015 Class II — HCG Low Dose 30 IU/0.1 mL, 5 Ml vial, Compounded Rx, Perry Drug Compounding Phar (November 7, 2014)
D-0270-2015 Class II — 2Ml HCG 10,000 U/ MB12 - 12,000 MCG/10 Ml Inj, 0.25ML (250IU), Rx, Perry Drug Co (November 7, 2014)
D-0268-2015 Class II — HCG 200 IU/mL Injection, 30Ml, 10 mL vials, Compounded Rx, Perry Drug Compoundin (November 7, 2014)