Montana Compounding Pharmacy Recalls Trimix Injectable Due to Sterility Concerns
Montana Compounding Pharmacy is recalling Trimix injectable vials because FDA inspectors observed objectionable conditions that raise concerns about the product's sterility.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable product, which poses a significant risk of serious injury or infection.
Plain-English summary
Montana Compounding Pharmacy in Missoula, Montana, is recalling specific vials of Trimix (A;PH,PA) (N) injectable. The product is a prescription-only compounded medication containing alprostadil, papaverine, and phentolamine, distributed in 1 mL vials.
The recall was initiated because FDA inspectors observed objectionable conditions during an inspection that raised a lack of assurance regarding the sterility of the product. The specific lot affected is Lot 04162015:77@4, with an expiration date of 6/8/2015. The product was distributed in Montana and North Dakota.
Patients who have received this medication should contact their healthcare provider for guidance. Consumers should not use the recalled product and should return it to the pharmacy or follow instructions from their healthcare provider.
The recalled product
- 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
- Manufacturer
- Montana Compounding Pharmacy
- Category
- Drug — Compounded Injectable
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 04162015:77@4
- Expiry date: 6/8/2015
Distribution
Part of a larger recall action
This product is one of 12 recalled by Montana Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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