Alprostadil Injection Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Alprostadil 10 mcg/ml Injection due to FDA inspection findings of 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, which corresponds to a Severe rating under the rubric for potential serious, reversible health consequences.
Plain-English summary
The Compounding Pharmacy of America is recalling Alprostadil 10 mcg/ml Injection, Sterile, Keep Frozen. The recall involves 130 mL of product distributed nationwide between November 2014 and May 2015. Specific lot numbers and expiration dates are listed in the recall documentation.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations raise concerns regarding the assurance of sterility and the overall quality of the product.
Healthcare providers and patients who have received this product should contact the recalling firm for further instructions on how to manage the recalled inventory or discontinue use.
The recalled product
- Product
- Alprostadil 10 mcg/ml Injection, 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 (20)
- All lots distributed between November 2014 and May 2015
- 12052014@40
- 6/3/2015
- 12182014@71
- 6/16/2015
- 01022015@12
- 7/1/2015
- 02112015@56
- 8/10/2015
- 02132015@47
- 8/12/2015
- 03062015@26
- 9/2/2015
- 03312015@23
- 9/27/2015
- 04162015@2
- 10/13/2015
- 05012015@26
- 10/28/2015
- 05072015@15
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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