The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1117-2015·Announced 2015-06-17

Montana Compounding Pharmacy Recalls Alprostadil Injectable Due to Sterility Concerns

Montana Compounding Pharmacy is recalling Alprostadil injectable vials because objectionable conditions were observed during an FDA inspection, raising 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 source text identifies the agency classification as Class II and cites 'Lack of Assurance of Sterility' for an injectable drug. Under the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects (or by extension, serious sterility failures in injectables which carry high risk) align with a Severe rating, particularly as Class I is reserved for reasonable probability of serious adverse health consequences or death, while Class II is next in severity for significant risks.

Plain-English summary

Montana Compounding Pharmacy in Missoula, Montana, is recalling Alprostadil (PFE1) Solution, 10 mcg/mL, injectable, 5 mL vials. The product is prescription-only and was distributed in Montana and North Dakota. The specific lot affected is 03252015:61@6, with an expiration date of 7/23/2015.

The recall was initiated due to a lack of assurance of sterility. This determination was made after objectionable conditions were observed during an inspection by the U.S. Food and Drug Administration. The agency has classified this recall as Class II.

Consumers and healthcare providers who have this specific lot of Alprostadil should stop using it and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the product.

The recalled product

Product
Alprostadil (PFE1), Solution, 10 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
Manufacturer
Montana Compounding Pharmacy
Category
Drug — 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 03252015:61@6
  • expiry date: 7/23/2015

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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