Home / Recalls / Key Pharmacy and Compounding Center / D-0708-2017

D-0708-2017 Class II Terminated

Recalled by Key Pharmacy and Compounding Center — Federal Way, WA

Recall Details

Product Type
Drugs
Report Date
May 24, 2017
Initiation Date
April 18, 2017
Termination Date
August 29, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6 vials

Product Description

5-MTHF 10ML MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10mLGlass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

Reason for Recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Distribution Pattern

Distributed nationwide in U.S.A., Australia and Canada.

Code Information

Lot # t11-17-2016@86, Exp 5/17/2017; t12-22-2016@103, Exp 7/4/2017; t01-09-2017@111, Exp 7/9/2017; t01-11-2017@118, Exp 7/11/2017; t01-18-2017@89, Exp 7/18/2017; t01-20-2017@83, Exp 7/23/2017.

Other recalls by Key Pharmacy and Compounding Center

  • D-0732-2017 Class II — PGE1 5ML MDV INJ, Injection, 40mcg/mL, Rx only, 5mL glass/Multiple Dose vial, P (April 18, 2017)
  • D-0778-2017 Class II — SODIUM BICARB 50ML MDV 8.4% (2 MOSMOL/ML) INJ, Injection, 8.40%, Rx only, 5mL (April 18, 2017)
  • D-0731-2017 Class II — PGE1 MDV 20MCG/ML INJ, Injection, 20mcg/mL, Rx only, packaged in a 5 mL, 10mL, a (April 18, 2017)
  • D-0776-2017 Class II — PYRIDOXAL-5-PHOS 10ML MDV 100MG/ML INJ, Injection, 100mg/mL, Rx only, 10mL Glass (April 18, 2017)
  • D-0737-2017 Class II — TRI MIX 10/30/0.5 *5ML* MDV MCG/MG/MG/ML INJ, Injection,10mcg/30mg/0.5mg/mL, Rx (April 18, 2017)
  • D-0765-2017 Class II — GLUTATHIONE INH *PV* 200MG/ML SOLN, Inhalation Solution, 200mg/mL, Rx only, 4mL (April 18, 2017)
  • D-0763-2017 Class II — FERR GLUC MDV 60MG/ML INJ, Injection, 60mg/mL, Rx only, Packaged in 5mL and 10mL (April 18, 2017)
  • D-0744-2017 Class II — TRI MIX 20/30/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 20mcg/30mg/1mg/mL, Rx only, (April 18, 2017)
  • D-0711-2017 Class II — ATROPINE SULFATE 0.01% OPHTH, Ophthalmic, 0.01%, Rx only, 15 mL Glass /Multiple (April 18, 2017)
  • D-0759-2017 Class II — VIT C/GSH 1.25%-1.25% OPHTH, Ophthalmic, 1.25%, Rx only, 15 mL Plastic/ Multiple (April 18, 2017)