Multi-event May 2015 FDA Recall Drug by Montana Compounding Pharmacy

This Multi-event Class II drug recall was voluntarily initiated by Montana Compounding Pharmacy on May 15, 2015 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility; objectionable conditions observed during a fda inspection. The product was distributed in MT and ND and the recall is currently terminated.

Reported Recall Events

D-1120-2015 TERMINATED D-1128-2015 TERMINATED D-1125-2015 TERMINATED D-1127-2015 TERMINATED D-1118-2015 TERMINATED D-1124-2015 TERMINATED D-1119-2015 TERMINATED D-1121-2015 TERMINATED D-1123-2015 TERMINATED D-1122-2015 TERMINATED D-1126-2015 TERMINATED D-1117-2015 TERMINATED

Recall Number: D-1120-2015

Reason for Recall
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Initiated
05-15-2015
Reported
06-17-2015
Quantity
1/5mL vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71275
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Montana Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
MT and ND
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-20-2016
Product Description About Product Description
Full technical description of the product.
Bimix (PHENT;PAP) (N), solution, (10/300) 1 - 30 mg/mL, injectable, 5ml vial, Rx only, compounded by Montana Compounding Pharmacy in Missoula, MT.

Batch or Lot Expiration Information

Lot# Lot 04102015:18@15, expiry date: 7/3/2015

Recall Number: D-1128-2015

Reason for Recall
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Initiated
05-15-2015
Reported
06-17-2015
Quantity
1/5 mL vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71275
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Montana Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
MT and ND
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-20-2016
Product Description About Product Description
Full technical description of the product.
Alprostadil (PFE1), solution, 30 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

Batch or Lot Expiration Information

Lot# Lot 04062015:18@1. Expiry date: 8/1/2015

Recall Number: D-1125-2015

Reason for Recall
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Initiated
05-15-2015
Reported
06-17-2015
Quantity
32/2 mL vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71275
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Montana Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
MT and ND
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-20-2016
Product Description About Product Description
Full technical description of the product.
Trimix (A;PH,PA) (N), injectable, 160 UG-1.2 mg-9.6/ mg/mL, 2 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT.

Batch or Lot Expiration Information

Lot# Lot 02112015:78@15, expiry dates: 6/1/2015; Lot 04062015:03@9, expiry dates: 6/8/2015

Recall Number: D-1127-2015

Reason for Recall
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Initiated
05-15-2015
Reported
06-17-2015
Quantity
2/5 mL vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71275
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Montana Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
MT and ND
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-20-2016
Product Description About Product Description
Full technical description of the product.
Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/297) 10UG, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

Batch or Lot Expiration Information

Lot# Lot 04082015:49@7; expiry date: 6/18/2015; Lot 04222015:25@8; expiry date: 7/3/2015.

Recall Number: D-1118-2015

Reason for Recall
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Initiated
05-15-2015
Reported
06-17-2015
Quantity
1/5 mL vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71275
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Montana Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
MT and ND
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-20-2016
Product Description About Product Description
Full technical description of the product.
Alprostadil (PFE1), solution, 20 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

Batch or Lot Expiration Information

Lot# Lot 04022015:93@10, expiry date: 7/31/2015

Recall Number: D-1124-2015

Reason for Recall
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Initiated
05-15-2015
Reported
06-17-2015
Quantity
1/1 mL. vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71275
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Montana Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
MT and ND
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-20-2016
Product Description About Product Description
Full technical description of the product.
Trimix (A;PH,PA) (N), injectable, 80 UG-0.6 mg-4.8 mg/mL, 1 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

Batch or Lot Expiration Information

Lot# Lot 04162015:77@4, Expiry date: 6/8/2015

Recall Number: D-1119-2015

Reason for Recall
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Initiated
05-15-2015
Reported
06-17-2015
Quantity
259/0.05 mL Syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71275
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Montana Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
MT and ND
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-20-2016
Product Description About Product Description
Full technical description of the product.
Avastin, solution, 1.25 mg/0.05mL, Injectable, Syringe, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

Batch or Lot Expiration Information

Lot# Lot 04202015:49@1, Expiry date: 5/20/2015; Lot 04272015:06@6, Expiry date: 6/2/2015; Lot 04282015:16@13, Expiry date: 6/12/2015; Lot 05062015:56@3, Expiry date: 5/24/2015

Recall Number: D-1121-2015

Reason for Recall
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Initiated
05-15-2015
Reported
06-17-2015
Quantity
20/4 mL vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71275
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Montana Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
MT and ND
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-20-2016
Product Description About Product Description
Full technical description of the product.
Glutathione INHALATION (PF), solution, 100mg/mL, 4 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT.

Batch or Lot Expiration Information

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

Recall Number: D-1123-2015

Reason for Recall
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Initiated
05-15-2015
Reported
06-17-2015
Quantity
20/1 mL vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71275
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Montana Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
MT and ND
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-20-2016
Product Description About Product Description
Full technical description of the product.
Hyaluronidase (RM ONLY), Injectable Solution, 150 U/mL, 10ML vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

Batch or Lot Expiration Information

Lot# Lot 02062015:06@3, expiry date: 5/17/2015; Lot 02272015:93@1, expiry date: 6/30/2015; Lot 03252015:92@7, expiry date: 6/30/2015; Lot 04162015:63@7, expiry date: 6/30/2015.

Recall Number: D-1122-2015

Reason for Recall
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Initiated
05-15-2015
Reported
06-17-2015
Quantity
10/3 mL vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71275
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Montana Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
MT and ND
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-20-2016
Product Description About Product Description
Full technical description of the product.
Glutathione INHALATION (PF), NASAL solution, 100 mg/mL, 3 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT

Batch or Lot Expiration Information

Lot# Lot 04102015:36@11, expiry date: 5/29/2015

Recall Number: D-1126-2015

Reason for Recall
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Initiated
05-15-2015
Reported
06-17-2015
Quantity
25/5 mL. vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71275
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Montana Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
MT and ND
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-20-2016
Product Description About Product Description
Full technical description of the product.
Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/240) 10UG, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

Batch or Lot Expiration Information

Lot# Lot 03112015:17@5; Expiry date: 6/1/2015; Lot 04042015:61@2; Expiry date: 6/3/2015; Lot 05022015:11@2; Expiry date: 6/16/2015

Recall Number: D-1117-2015

Reason for Recall
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Initiated
05-15-2015
Reported
06-17-2015
Quantity
1/5mL vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71275
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Montana Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
MT and ND
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-20-2016
Product Description About Product Description
Full technical description of the product.
Alprostadil (PFE1), Solution, 10 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

Batch or Lot Expiration Information

Lot# Lot 03252015:61@6, expiry date: 7/23/2015