The Recall Desk
SevereFDA (Drugs)·D-0112-2016·Announced 2015-11-04

FDA Recalls Injectable Solution Due to Lack of Sterility Assurance

FDA is recalling a compounded injectable solution due to a lack of assurance of sterility. The product is distributed nationwide.

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 the hazard involves a lack of sterility assurance in an injectable drug, which poses a significant risk of serious injury or infection.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling a compounded injectable solution containing papaverine, phentolamine, atropine, and prostaglandin. The product is manufactured by JD & SN Inc., dba Moses Lake Professional Pharmacy, and is distributed nationwide.

The recall is being conducted because of a lack of assurance of sterility. The source text indicates that all sterile human compounded drugs within the expiry date are affected by this issue.

Consumers and healthcare providers should stop using the affected product and contact the recalling firm or their healthcare provider for further instructions.

The recalled product

Product
PAPAVERINE/PHENTOLAMINE/ATROPINE/PROSTAGLANDIN, Injectable Solution, 9 MG/1 MG/0. 1MG/10MCG/ML, syringe 10 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
Affected units
1

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 (1)

  • t05222015@6

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 101 recalled by JD & SN Inc., dba Moses Lake Professional 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 101 products in this recall →