The Recall Desk
SevereFDA (Drugs)·D-1099-2020·Announced 2020-04-15

Innovative Compounding Pharmacy Recalls Alprostadil Injection Due to Sterility Concerns

Innovative Compounding Pharmacy is recalling Alprostadil, Papaverine, and Phentolamine injection due to a lack of assurance of sterility. The product was distributed to patients in California, Maine, and Texas.

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 involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious health consequences such as infection.

Plain-English summary

Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy is recalling Alprostadil 10mcg/Papaverine 30mg/Phentolamine 1mg/ml Injectable Solution, 5 mL. The recall was initiated because of a lack of assurance of sterility in the product.

The affected product is identified by Lot #02282020@30 and has an expiration date of 04/28/2020. The recall is classified as FDA Class II. Distribution records indicate that the product was sent to patients in California, Maine, and Texas.

Consumers who have this specific lot of medication should contact their healthcare provider or the recalling firm for instructions on how to proceed. The FDA has not reported any illnesses or injuries associated with this recall in the provided source text.

The recalled product

Product
Alprostadil 10mcg/Papaverine 30mg/Phentolamine 1mg/ml lnj Soln, 5 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530

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 (2)

  • Lot #02282020@30
  • Expires after 04/28/2020

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 5 recalled by Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy 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 5 products in this recall →