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.
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 the hazard involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or infection.
Plain-English summary
Montana Compounding Pharmacy is recalling Alprostadil (PFE1), solution, 30 mcg/mL, injectable, 5 mL vials. 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 affected product is prescription-only and was distributed in Montana and North Dakota. The specific lot number is 04062015:18@1, with an expiration date of August 1, 2015.
Patients and healthcare providers should stop using the recalled product and contact their healthcare provider for further instructions or to obtain a replacement.
The recalled product
- Product
- Alprostadil (PFE1), solution, 30 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
- Manufacturer
- Montana Compounding Pharmacy
- Category
- Drug — Injectable
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 (1)
- Lot 04062015:18@1. Expiry date: 8/1/2015
Distribution
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.
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