The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1126-2015·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 due to lack of assurance of sterility observed during an FDA inspection.

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 involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of infection or adverse health consequences, meeting the criteria for a Severe rating.

Plain-English summary

Montana Compounding Pharmacy is recalling 25 vials of Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/240) 10UG, 5 mL vials. The product is prescription-only and was distributed in Montana and North Dakota. The recall involves specific lots with expiry dates ranging from June 1, 2015, to June 16, 2015.

The recall was initiated due to a lack of assurance of sterility and objectionable conditions 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 on next steps. The specific lots affected are Lot 03112015, Lot 04042015, and Lot 05022015.

The recalled product

Product
Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/240) 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 (6)

  • 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

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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