Agency classClass IIOur severity:Severe FDA (Drugs)·D-1439-2015·Announced 2015-09-23

Alprostadil Injection Recalled Due to Sterility Assurance Concerns

The Compounding Pharmacy of America is recalling Alprostadil 40 mcg/ml Injection 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 source text identifies GMP violations impacting sterility, which is a significant safety risk for an injectable drug. Per the rubric, FDA Class II recalls with significant injury/property-damage reports or structural defects are Severe; while no specific injuries are reported, the risk of sterility failure in an injectable is a significant hazard warranting a score of 4.

Plain-English summary

The Compounding Pharmacy of America is recalling Alprostadil 40 mcg/ml Injection, Sterile, Keep Frozen. The recall involves 76 mL total of the product distributed nationwide between November 2014 and May 2015. Specific lot codes and expiration dates are listed in the official recall documentation.

The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility. This lack of assurance of sterility poses a risk to patients using the medication.

Healthcare providers and patients should stop using the recalled product and contact the recalling firm or their healthcare provider for further instructions. The FDA classifies this as a Class II recall.

The recalled product

Product: Alprostadil 40 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — 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 (11)

All lots distributed between November 2014 and May 2015
01082015@34
7/7/2015
12162014@46
6/14/2015
02032015@98
8/2/2015
02112015@79
8/10/2015
02192015@15
8/18/2015

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.

See all 382 products in this recall →

Same manufacturer · The Compounding Pharmacy of America

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Same hazard · sterility