Alprostadil Injection Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling PGE 80 (Alprostadil) 80 mcg/ml Injection because an FDA inspection identified GMP violations that may impact 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential sterility impacts in a sterile injection product are categorized as Severe (Score 4), as they may cause temporary or medically reversible adverse health consequences.
Plain-English summary
The Compounding Pharmacy of America is recalling PGE 80 (Alprostadil) 80 mcg/ml Injection, Multi-Dose Vial, Sterile, Keep Frozen. The product is a sterile injection with a total volume of 195 ml. The recall is being conducted because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product.
The recall covers all lots distributed between November 2014 and May 2015. Specific lot codes include 02112015@32, 04012015@30, and 04272015@38. The product was distributed nationwide.
Healthcare providers and patients should stop using the recalled product and contact the recalling firm for further instructions. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- PGE 80 (Alprostadil) 80 mcg/ml Injection, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Sterile Injection
- 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 (7)
- All lots distributed between November 2014 and May 2015
- 02112015@32
- 8/10/2015
- 04012015@30
- 9/28/2015
- 04272015@38
- 10/24/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 382 recalled by The Compounding Pharmacy of America 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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