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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71275

12 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 15, 2015
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Montana Compounding Pharmacy

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

12 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 12

Alprostadil (PFE1), Solution, 10 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

D-1117-2015
Recall number
D-1117-2015
Initiated
May 15, 2015
Classification
Class II
Status
Terminated
Quantity
1/5mL vial

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

MT and ND

drug · product 2 of 12

Alprostadil (PFE1), solution, 20 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

D-1118-2015
Recall number
D-1118-2015
Initiated
May 15, 2015
Classification
Class II
Status
Terminated
Quantity
1/5 mL vial

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

MT and ND

drug · product 3 of 12

Avastin, solution, 1.25 mg/0.05mL, Injectable, Syringe, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

D-1119-2015
Recall number
D-1119-2015
Initiated
May 15, 2015
Classification
Class II
Status
Terminated
Quantity
259/0.05 mL Syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

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;

Distribution pattern

MT and ND

drug · product 4 of 12

Bimix (PHENT;PAP) (N), solution, (10/300) 1 - 30 mg/mL, injectable, 5ml vial, Rx only, compounded by Montana Compounding Pharmacy in Missoula, MT.

D-1120-2015
Recall number
D-1120-2015
Initiated
May 15, 2015
Classification
Class II
Status
Terminated
Quantity
1/5mL vial

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

MT and ND

drug · product 5 of 12

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

D-1121-2015
Recall number
D-1121-2015
Initiated
May 15, 2015
Classification
Class II
Status
Terminated
Quantity
20/4 mL vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

MT and ND

drug · product 6 of 12

Glutathione INHALATION (PF), NASAL solution, 100 mg/mL, 3 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT

D-1122-2015
Recall number
D-1122-2015
Initiated
May 15, 2015
Classification
Class II
Status
Terminated
Quantity
10/3 mL vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

MT and ND

drug · product 7 of 12

Hyaluronidase (RM ONLY), Injectable Solution, 150 U/mL, 10ML vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

D-1123-2015
Recall number
D-1123-2015
Initiated
May 15, 2015
Classification
Class II
Status
Terminated
Quantity
20/1 mL vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

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.

Distribution pattern

MT and ND

drug · product 8 of 12

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

D-1124-2015
Recall number
D-1124-2015
Initiated
May 15, 2015
Classification
Class II
Status
Terminated
Quantity
1/1 mL. vial

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

MT and ND

drug · product 9 of 12

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.

D-1125-2015
Recall number
D-1125-2015
Initiated
May 15, 2015
Classification
Class II
Status
Terminated
Quantity
32/2 mL vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

MT and ND

drug · product 10 of 12

Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/240) 10UG, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

D-1126-2015
Recall number
D-1126-2015
Initiated
May 15, 2015
Classification
Class II
Status
Terminated
Quantity
25/5 mL. vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

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;

Distribution pattern

MT and ND

drug · product 11 of 12

Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/297) 10UG, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

D-1127-2015
Recall number
D-1127-2015
Initiated
May 15, 2015
Classification
Class II
Status
Terminated
Quantity
2/5 mL vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

MT and ND

drug · product 12 of 12

Alprostadil (PFE1), solution, 30 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

D-1128-2015
Recall number
D-1128-2015
Initiated
May 15, 2015
Classification
Class II
Status
Terminated
Quantity
1/5 mL vial

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

MT and ND