Agency classClass IIOur severity:Severe FDA (Drugs)·D-1620-2015·Announced 2015-09-23

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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: sterility
gmp-violation

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.

See all 382 products in this recall →

Same manufacturer · The Compounding Pharmacy of America

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Same hazard · sterility