The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0818-2020·Announced 2020-02-05

Medical Park Pharmacy Recalls Tadalafil 20 mg Troche Due to Expired Components

MPRX, Inc. dba Medical Park Pharmacy is recalling Tadalafil 20 mg Troche because the products were compounded using expired components and have incorrect or missing lot and expiration dates.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the issue as labeling errors and the use of expired components without reporting any specific illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

MPRX, Inc. dba Medical Park Pharmacy is recalling Tadalafil 20 mg Troche. The recall involves 9 bottles of the product distributed in Texas. The specific lots affected are 61137:42 (Use by: 03/08/2020), 61324:99 (Use by: 04/04/2020), and 60856:42 (Use by: 02/02/2020).

The recall was initiated due to labeling issues, specifically incorrect or missing lot and/or expiration dates. Additionally, the source text states that the products were compounded using expired components.

Consumers who possess these specific lots of Tadalafil 20 mg Troche should stop using the product and contact the recalling firm or their healthcare provider for instructions on how to return or dispose of the medication.

The recalled product

Product
Tadalafil 20 mg Troche
Manufacturer
MPRX, Inc. dba Medical Park Pharmacy
Category
Drug — Compounded Medication
Hazard
Affected units
9

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)

  • Lots: 61137:42 Use by: 03/08/2020
  • 61324:99 Use by: 04/04/2020
  • 60856:42 Use by: 02/02/2020

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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