Agency classClass IIIOur severity:Low FDA (Drugs)·D-0243-2019·Announced 2018-11-21

Right Value Drug Stores Recalls Tadalafil SR 12 mg Capsules for Misbranding

Right Value Drug Stores, Inc. is recalling Tadalafil SR 12 mg capsules distributed in California due to labeling misbranding.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a labeling error (misbranding) without reported injuries.

Plain-English summary

Right Value Drug Stores, Inc. is recalling Tadalafil SR 12 mg Capsules packed in 8, 13, 20, 30, 40, or 60 dram screw top pill bottles. The product was distributed in California. The recall is due to labeling misbranding, classified as 'Labeling Not Elsewhere Classified: Misbranding.'

The affected product is identified by NDC 99999-9969-51. Specific lots involved include 07232018@15 with an expiration date of 1/19/2019, and 08102018@10 with an expiration date of 2/6/2019. The product was associated with Carie Boyd's Prescription Shop in Hurst, TX.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

The recalled product

Product: Tadalafil SR 12 mg Capsules packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122 Grapevine Hwy. Hurst, TX 76054 817-282-9376 NDC 99999-9969-51
Manufacturer: Right Value Drug Stores, Inc.
Category: Drug — Prescription Medication
Hazard: mis-labeling
Affected units: 180

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: 07232018@15 Exp. 1/19/2019
08102018@10 Exp. 2/6/2019

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 4 recalled by Right Value Drug Stores, Inc. 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 4 products in this recall →

Same manufacturer · Right Value Drug Stores, Inc.

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