The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0814-2020·Announced 2020-02-05

Sildenafil 200 mg Troche Recall for Labeling and Expiry Issues

Sildenafil 200 mg Troche is recalled for incorrect labeling and being compounded with expired components. Consumers in Texas should check their bottles and contact the manufacturer for instructions.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: An FDA Class II recall for a compounded drug using expired components with incorrect labeling, presenting a potential risk of harm where no injuries have yet been reported. This meets the rubric criteria for High severity risk-of-harm products without reported illness.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has announced a recall of Sildenafil 200 mg Troche (Clinic), compounded by MPRX, Inc. dba Medical Park Pharmacy. The product is being recalled because of incorrect or missing lot and/or expiration date labeling, and because the products were compounded using expired components.

This recall affects products distributed in Texas, specifically Lot 61392:42 with an expiration date of 05/05/2020. While no specific illnesses or injuries have been reported, the use of expired components during compounding poses a potential health risk.

Consumers who have purchased this product should verify the lot number and expiration date on their bottle. They are advised to contact the recalling firm, MPRX, Inc. dba Medical Park Pharmacy, or the FDA for further instructions on returning or discontinuing use of the medication.

The recalled product

Product
Sildenafil 200 mg Troche (Clinic)
Manufacturer
MPRX, Inc. dba Medical Park Pharmacy
Category
Drug
Hazard
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)

  • Lot: 61392:42 Use by: 05/05/2020

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 18 recalled by MPRX, Inc. dba Medical Park 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 18 products in this recall →

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