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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug

Montana Compounding Pharmacy: Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Agency Publication Date: June 9, 2015
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Affected Products

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

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

Lot Numbers:
03252015
Product: Alprostadil (PFE1), solution, 20 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

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

Lot Numbers:
04022015
Product: Avastin, solution, 1.25 mg/0.05mL, Injectable, Syringe, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

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;

Lot Numbers:
04202015
04272015
04282015
05062015
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.

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

Lot Numbers:
04102015
Product: Glutathione INHALATION (PF), solution, 100mg/mL, 4 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT.

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

Lot Numbers:
04102015
Product: Glutathione INHALATION (PF), NASAL solution, 100 mg/mL, 3 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT

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

Lot Numbers:
04102015
Product: Hyaluronidase (RM ONLY), Injectable Solution, 150 U/mL, 10ML vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

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.

Lot Numbers:
02062015
02272015
03252015
04162015
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

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

Lot Numbers:
04162015
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.

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

Lot Numbers:
02112015
04062015
Product: Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/240) 10UG, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

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;

Lot Numbers:
03112015
04042015
05022015
Product: Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/297) 10UG, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

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

Lot Numbers:
04082015
04222015
Product: Alprostadil (PFE1), solution, 30 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

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

Lot Numbers:
04062015

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 71275
Status: Resolved
Manufacturer: Montana Compounding Pharmacy
Manufactured In: United States
Units Affected: 12 products (1/5mL vial; 1/5 mL vial; 259/0.05 mL Syringes; 1/5mL vial; 20/4 mL vials; 10/3 mL vials; 20/1 mL vials; 1/1 mL. vial; 32/2 mL vials; 25/5 mL. vials; 2/5 mL vials; 1/5 mL vial)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.