Thursday, September 4, 2014

Look at the Compounded Medications on the FDA September 2, 2014 Enforcement Report; Source found here http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=09032014&lang=eng#drugs

Drugs MINERAL IV Injection, compounded by Abrams Royal Pharmacy, Inc., Dallas, TX Lot number 11142013@74 Class I Non-Sterility; analytical results found product to contain Sphingomonas paucimobilis Abrams Royal Pharamacy
Drugs All Unexpired Sterile Drug Products, compounded by Abrams Royal Pharmacy Inc., Dallas, TX All unexpired lots of sterile drug products Class II Lack of Assurance of Sterility Abrams Royal Pharamacy
Drugs VIVITROL (naltrexone for extended-release injectable suspension); 380 mg vial NDC 65757-300-01; RX Only Manufactured and marketed by Alkermes, Inc., Waltham, MA 02451. Batch Number: 412-3732AA; expiration date 07/2016 (NDC# 65757-302-02; Kit Pacaging Lot Number: 2013-021; expiration date 07/2016 (NDC# 65757-300-01. Class II Customer complaints for failure to deliver the dose. Alkermes, Inc.
Drugs Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville IN 46060 NDC#: 45183-0234-68. Lot #: E21294K3C Exp Date: 6/29/2014 Class I Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. Pharmakon Pharmaceuticals
Drugs Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag, Rx Only. Labeled A) 50 mL, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060. NDC#: 45183-0989-41. B) 100 mL, Pharmakon Pharmaceuticals, 14450 Getz Rd., Noblesville, IN 888-660-6715. NDC#: 45183-0796-48. A) Lot #: E21294DK1C; Exp Date: 05/22/2014 B) Lot #: E21294DK3C; Exp Date: 06/08/2014 Class I Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. Pharmakon Pharmaceuticals
Drugs Glycopyrrolate 0.2 mg/ml, 5 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060, NDC#: 45183-0965-70. Lot #: E131210.212 Exp: 07/14/2014 Class II Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. Pharmakon Pharmaceuticals
Drugs Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per 2 mL, 3 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Road, Noblesville, IN. NDC: 45183-0105-78. Lot #: E0333282R; Exp: 7/13/2014 Class I Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. Pharmakon Pharmaceuticals
Drugs PEDIATRIC CARDIOPLEGIA, 255 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150 Lot # 13-920741-0-1 EXP 21 JUN 2014 Class I Non Sterility; microbial contamination identified as Aspergillus species Central Admixture Pharmacy Services, Inc.
Drugs del Nido Cardioplegia with Lidocaine 1052.8 ml, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150 Lot# 13-920742-0-1 EXP 21 JUN 2014 and Lot# 13-920452-0-1 through 13-920452-0-30, EXP 21 JUN 2014 Class I Non Sterility; microbial contamination identified as Aspergillus species Central Admixture Pharmacy Services, Inc.
Drugs adenosine 90 mg in 0.9% sodium chloride/90 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150 Lot# 13-920757-0-1 through Lot# 13-920757-0-5 (5 total doses) EXP 06 JUL 2014 Class I Non Sterility; microbial contamination identified as Aspergillus species Central Admixture Pharmacy Services, Inc.
Drugs LOW Potassium Cardioplegia 792 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150 Lot # 13-920739-01 through Lot # 13-920739-04 (4 total doses) EXP 21 Jun 2014 Class I Non Sterility; microbial contamination identified as Aspergillus species

 
Central Admixture Pharmacy Services, Inc.

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