Alprostadil Injection Recalled for Potential Sterility Issues
The Compounding Pharmacy of America is recalling Alprostadil 100 mcg/ml injections due to FDA inspection findings 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, and the hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury.
Plain-English summary
The Compounding Pharmacy of America is recalling 25 ml vials of PGE 2 (Alprostadil) 100 mcg/ml, sterile, keep frozen. The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility.
The affected product was distributed nationwide between November 2014 and May 2015. Specific lots involved include 04282015@46, 04302015@31, and 05072015@36.
Consumers and healthcare providers should stop using the recalled product and contact the manufacturer or their healthcare provider for further instructions.
The recalled product
- Product
- PGE 2 (Alprostadil) 100 mcg/ml, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Injectable
- 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
- 04282015@46
- 10/25/2015
- 04302015@31
- 10/27/2015
- 05072015@36
- 11/3/2015
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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