Home / Recalls / Nora Apothecary and Alternative Therapies, Inc. / D-491-2013

D-491-2013 Class II Terminated

Recalled by Nora Apothecary and Alternative Therapies, Inc. — Indianapolis, IN

Recall Details

Product Type
Drugs
Report Date
June 5, 2013
Initiation Date
April 22, 2013
Termination Date
August 1, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2

Product Description

Glutathione 200mg/ml Inj SDV: 3x50ml 14 day expiration, 1x50ml 21 day expiration

Reason for Recall

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Distribution Pattern

Nationwide

Code Information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Other recalls by Nora Apothecary and Alternative Therapies, Inc.

  • D-467-2013 Class II — Vancomycin Opth Soln 25mg/ml PF, 10ml Opthalmic Soln, 10 day expiration, (April 22, 2013)
  • D-479-2013 Class II — HCG Inj 500un/ml MDV, 5 ml Subcutaneous, 30 day expiration, (April 22, 2013)
  • D-470-2013 Class II — Tobramycin Opth Soln 14mg/ml, 7ml Opthalmic Soln, 10 day expiration, (April 22, 2013)
  • D-454-2013 Class II — Bimix Inj 30:0.5 MDV, 5 ml syr Penile Injection, 90 day expiration, (April 22, 2013)
  • D-483-2013 Class II — Methylcobalamin Inj 1mg/ml MDV, 10 ml, 15 ml, 20 ml, 30 ml, 4x30 ml Subcutaneou (April 22, 2013)
  • D-468-2013 Class II — Vancomycin Opth Soln 30mg/ml PRES, 10ml Opthalmic Soln, 30 day expiration, (April 22, 2013)
  • D-484-2013 Class II — Methylcobalamin Inj 5mg/ml MDV: 5 ml, 10 ml, 12 ml, 20 ml Subcutaneous, 90 day (April 22, 2013)
  • D-490-2013 Class II — Gentamicin 24mg/60ml Irrigation, 15x60ml Syr Irrigation, 14 day expiration, (April 22, 2013)
  • D-481-2013 Class II — Hydroxycobalamin Inj 1 mcg/ml MDV, 2x30ml Subcutaneous, 90 day expiration, (April 22, 2013)
  • D-458-2013 Class II — PGE-1 Inj 20mcg/ml MDV: 5ml, 7ml, 10ml, 20ml Penile Injection, 90 day expiratio (April 22, 2013)