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.
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 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
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
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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