The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0819-2020·Announced 2020-02-05

Medical Park Pharmacy Recalls Tadalafil 6 mg Capsules for Labeling Errors

MPRX, Inc. dba Medical Park Pharmacy is recalling Tadalafil 6 mg Capsules due to incorrect or missing lot and expiration dates and the use of expired components.

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 and involves labeling errors and the use of expired components, which aligns with the rubric for moderate severity involving minor labeling errors or low-risk contamination without reported serious injuries.

Plain-English summary

MPRX, Inc. dba Medical Park Pharmacy is recalling Tadalafil 6 mg Capsules. The recall involves 7 bottles of the product. The affected lots are 61229:26 and 61229:42, both with a use-by date of 03/25/2020.

The recall was initiated because of labeling errors, specifically incorrect or missing lot and/or expiration dates. Additionally, the products were compounded using expired components. The agency has classified this recall as Class II.

The affected products were distributed in Texas (TX). Consumers who have these specific lots of Tadalafil 6 mg Capsules should stop using them and contact the recalling firm or their healthcare provider for instructions on disposal or replacement.

The recalled product

Product
Tadalafil 6 mg Capsule
Affected units
7

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)

  • Lots: 61229:26 Use by: 03/25/2020
  • 61229:42 Use by: 03/25/2020

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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