The Recall Desk
SevereFDA (Drugs)·D-1125-2015·Announced 2015-06-17

Montana Compounding Pharmacy Recalls Trimix Injectable Due to Sterility Concerns

Montana Compounding Pharmacy is recalling specific lots of Trimix injectable vials because FDA inspectors observed objectionable conditions that raise concerns about sterility.

What this means for you

Illness, injury, or structural failure has been reported. 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. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectables) are categorized as Severe (Score 4), particularly when structural or process defects are identified by the agency.

Plain-English summary

Montana Compounding Pharmacy in Missoula, Montana, is recalling 32 vials of Trimix (A;PH,PA) (N) injectable, 2 mL vials. The affected products are prescription-only compounded medications distributed in Montana and North Dakota. The recall involves Lot 02112015:78@15 with an expiry date of 6/1/2015, and Lot 04062015:03@9 with an expiry date of 6/8/2015.

The recall was initiated due to a lack of assurance of sterility. This determination was made after objectionable conditions were observed during a U.S. Food and Drug Administration (FDA) inspection. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Patients who have received this medication should contact their healthcare provider or pharmacist for guidance. Consumers should not use the recalled product and should return it to the pharmacy or follow instructions provided by the recalling firm.

The recalled product

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.
Manufacturer
Montana Compounding Pharmacy
Category
Drug — Compounded Injectable
Hazard

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 (4)

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

Distribution

Distributed in 2 states:

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.

See all 12 products in this recall →

Related recalls

Same manufacturer · Montana Compounding Pharmacy

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Same hazard · sterility

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