Compounded Alprostadil Recalled for Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling PGE 150 (Alprostadil) 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. Per the rubric, FDA Class II recalls with potential sterility issues in injectable products are categorized as Severe (Score 4) due to the risk of infection or other significant health consequences, even without reported hospitalizations in the text.
Plain-English summary
The Compounding Pharmacy of America is voluntarily recalling PGE 150 (Alprostadil) 150 mcg/ml, a sterile multi-dose vial product. The recall was initiated following an FDA inspection that identified Good Manufacturing Practice (GMP) violations. These violations raise concerns regarding the assurance of sterility and overall product quality.
The affected product was distributed nationwide. The recall covers all lots distributed between November 2014 and May 2015, specifically including lot numbers 02112015@33 and 04272015@36. The total quantity involved is 188 ml.
Patients and healthcare providers should stop using the recalled product and contact their healthcare provider for guidance on alternative treatments. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- PGE 150 (Alprostadil) 150 mcg/ml, ml, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Compounded 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 (3)
- All lots distributed between November 2014 and May 2015
- 02112015@33
- 04272015@36
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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