The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1127-2015·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.

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. According to the rubric, an FDA Class II recall with potential for adverse health consequences (such as sterility issues in an injectable) corresponds to a severity score of 4 (Severe), as it is not a Class I (Critical) but involves significant risk.

Plain-English summary

Montana Compounding Pharmacy in Missoula, Montana, is recalling specific lots of Trimix (PGE1;PHENT;PAP) injectable vials. The product is a prescription-only compounded medication available in 5 mL vials. The recall affects Lot 04082015 (expiry date 6/18/2015) and Lot 04222015 (expiry date 7/3/2015). These products were distributed in Montana and North Dakota.

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.

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 (PGE1;PHENT;PAP) (N), injectable, (100/10/297) 10UG, 5 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 04082015:49@7
  • expiry date: 6/18/2015
  • Lot 04222015:25@8
  • expiry date: 7/3/2015.

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 →

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