The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1120-2015·Announced 2015-06-17

Montana Compounding Pharmacy Recalls Bimix Injectable Due to Sterility Concerns

Montana Compounding Pharmacy is recalling Bimix injectable vials because FDA inspectors observed objectionable conditions that raise concerns about sterility assurance.

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 FDA classified this recall as Class II, and the hazard involves a lack of assurance of sterility in an injectable product, which poses a significant risk of serious health consequences such as infection.

Plain-English summary

Montana Compounding Pharmacy in Missoula, MT, is recalling Bimix (PHENT;PAP) (N) injectable solution, 5ml vials. The product is compounded and distributed in Montana and North Dakota. The specific lot affected is 04102015:18@15, with an expiry date of 7/3/2015.

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.

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

The recalled product

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.
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 (2)

  • Lot 04102015:18@15
  • 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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