Home / Recalls / Montana Compounding Pharmacy / D-1121-2015

D-1121-2015 Class II Terminated

Recalled by Montana Compounding Pharmacy — Missoula, MT

Recall Details

Product Type
Drugs
Report Date
June 17, 2015
Initiation Date
May 15, 2015
Termination Date
December 20, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
20/4 mL vials

Product Description

Glutathione INHALATION (PF), solution, 100mg/mL, 4 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT.

Reason for Recall

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Distribution Pattern

MT and ND

Code Information

Lot 04102015:70@12; expiry date 5/28/2015.

Other recalls by Montana Compounding Pharmacy

  • D-1128-2015 Class II — Alprostadil (PFE1), solution, 30 mcg/mL, injectable, 5 mL vial, Rx only, compoun (May 15, 2015)
  • D-1125-2015 Class II — Trimix (A;PH,PA) (N), injectable, 160 UG-1.2 mg-9.6/ mg/mL, 2 mL vial, Rx only, (May 15, 2015)
  • D-1127-2015 Class II — Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/297) 10UG, 5 mL vial, Rx only, (May 15, 2015)
  • D-1123-2015 Class II — Hyaluronidase (RM ONLY), Injectable Solution, 150 U/mL, 10ML vial, Rx only, comp (May 15, 2015)
  • D-1122-2015 Class II — Glutathione INHALATION (PF), NASAL solution, 100 mg/mL, 3 mL vial, Rx only, disp (May 15, 2015)
  • D-1120-2015 Class II — Bimix (PHENT;PAP) (N), solution, (10/300) 1 - 30 mg/mL, injectable, 5ml vial, Rx (May 15, 2015)
  • D-1124-2015 Class II — Trimix (A;PH,PA) (N), injectable, 80 UG-0.6 mg-4.8 mg/mL, 1 mL vial, Rx only, co (May 15, 2015)
  • D-1119-2015 Class II — Avastin, solution, 1.25 mg/0.05mL, Injectable, Syringe, Rx only, compounded by M (May 15, 2015)
  • D-1118-2015 Class II — Alprostadil (PFE1), solution, 20 mcg/mL, injectable, 5 mL vial, Rx only, compoun (May 15, 2015)
  • D-1117-2015 Class II — Alprostadil (PFE1), Solution, 10 mcg/mL, injectable, 5 mL vial, Rx only, compoun (May 15, 2015)