Endo Recalls EDEX Alprostadil Injection Due to Sterility Assurance Defect
Endo Pharmaceuticals is recalling 5,086 cartridges of EDEX (alprostadil) 10mcg injection due to a defective container that compromises sterility assurance.
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, and the hazard involves a lack of sterility assurance in an injectable drug, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
Endo Pharmaceuticals, Inc. is recalling 5,086 cartridges of EDEX (alprostadil for injection) 10mcg, packaged in a 2 pack carton. The affected product is identified by Lot # 207386 with an expiration date of May 2019. The product is a prescription-only medication manufactured in Germany for Actient Pharmaceuticals, LLC, and distributed nationwide within the United States.
The recall was initiated due to a lack of assurance of sterility caused by a defective container. This defect results in a lack of sterility assurance for the product. No specific illnesses or injuries are reported in the source text.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions. The product is an intracavernous injection used for the treatment of erectile dysfunction.
The recalled product
- Product
- EDEX (ALPROSTADIL)
- Brand
- EDEX
- Manufacturer
- Endo Pharmaceuticals, Inc.
- Category
- Drug — Prescription Injection
- Affected units
- 5,086
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 #: 207386
- Exp. May 2019
Distribution
Distributed nationwide across the United States.
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