Alprostadil Injection Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Alprostadil 50 mcg/ml Injection because an FDA inspection found 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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in a sterile injection, which poses a significant risk of serious injury or hospitalization.
Plain-English summary
The Compounding Pharmacy of America is recalling Alprostadil 50 mcg/ml Injection, Sterile, Keep Frozen. The recall is due to a lack of assurance of sterility. An FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility.
The affected product is distributed nationwide. The recall covers all lots distributed between November 2014 and May 2015. Specific lot codes include 02032015@24 and 8/2/2015. The product quantity is 7 mL total.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Alprostadil 50 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — 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 (3)
- All lots distributed between November 2014 and May 2015
- 02032015@24
- 8/2/2015
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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