The Recall Desk
SevereFDA (Drugs)·D-1118-2015·Announced 2015-06-17

Montana Compounding Pharmacy Recalls Alprostadil Injectable Due to Sterility Concerns

Montana Compounding Pharmacy is recalling Alprostadil injectable vials due to lack of assurance of sterility and objectionable conditions observed during an FDA inspection.

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, which corresponds to a Severe severity score under the rubric for drug recalls involving potential serious health consequences.

Plain-English summary

Montana Compounding Pharmacy is recalling Alprostadil (PFE1), solution, 20 mcg/mL, injectable, 5 mL vials. The recall was initiated because of a lack of assurance of sterility and objectionable conditions observed during a U.S. Food and Drug Administration (FDA) inspection.

The affected product is prescription-only and was distributed in Montana and North Dakota. The specific lot number is 04022015:93@10, with an expiration date of 7/31/2015.

Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product
Alprostadil (PFE1), solution, 20 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 04022015:93@10
  • expiry date: 7/31/2015

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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