Home / Recalls / Well Care Compounding Pharmacy / D-1006-2016

D-1006-2016 Class II Terminated

Recalled by Well Care Compounding Pharmacy — Las Vegas, NV

Recall Details

Product Type
Drugs
Report Date
June 15, 2016
Initiation Date
May 17, 2016
Termination Date
January 13, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
869 Units (Total All Products)

Product Description

QUAD-MIX #1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Reason for Recall

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Distribution Pattern

NV

Code Information

Lot #: 01292016:04@9, Exp.07/27/2016; Lot #: 04082016: 84@17, Exp. 10/09/2016.

Other recalls by Well Care Compounding Pharmacy

  • D-1019-2016 Class II — TRI-MIX # 4, packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las (May 17, 2016)
  • D-0980-2016 Class II — ATROPINE SULFATE 0.5% Ophthalmic Drops, packaged in 5mL droppers, Rx only, Well (May 17, 2016)
  • D-1003-2016 Class II — MYERS' COCKTAIL, packaged in 37 mL vials, Rx only, Well Care Compounding Pharma (May 17, 2016)
  • D-0988-2016 Class II — 1-HCG 1000 IU/ML, packaged in 5mL and 10mL vials, Rx only, Well Care Compounding (May 17, 2016)
  • D-1015-2016 Class II — TESTOSTERONE CYPIONATE 200MG/ML, packaged in 5mL vials, Rx only, Well Care Comp (May 17, 2016)
  • D-0983-2016 Class II — ESTRADIOL VALERATE 20MG/ML, packaged in 5mL vials, Rx only, Well Care Compoundin (May 17, 2016)
  • D-1000-2016 Class II — METHYLCOBALAMIN 1 MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compo (May 17, 2016)
  • D-0981-2016 Class II — ESTRADIOL CYPIONATE 10 MG/ML, packaged in 5mL vials, Rx only, Well Care Compound (May 17, 2016)
  • D-0979-2016 Class II — ALPHA LIPOIC ACID 25MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding (May 17, 2016)
  • D-1009-2016 Class II — SUPER TRI-MIX #1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy (May 17, 2016)