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Class II: temporary or reversible health riskTerminated

RemedyRepack Tadalafil 5 mg tablets Recall

Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc

RemedyRepack Inc. · Indiana, PA

Risk level
Class II
Reported by FDA
Apr 12, 2023
Recall ID
D-0497-2023
Check your lot numberHow we source this data

Summary

RemedyRepack recalled Tadalafil 5 mg tablets starting Mar 20, 2023. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0497-2023 on Apr 12, 2023. Reason: cGMP Deviations. Status: Terminated.

Why it was recalled

cGMP Deviations

Product description

Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2972-00

Lot numbers, UPCs & expiration codes

Lot #: B1635780-040522, Exp. Date 04/30/2023

Where it was sold

RemedyRepack distributed product to consignees nationwide within the United States

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0497-2023
Classification
Class II
Status
Terminated
Recall initiated
Mar 20, 2023
FDA report date
Apr 12, 2023
Quantity
16 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
RemedyRepack Inc.

Original FDA data

Every field from FDA enforcement report D-0497-2023, exactly as published.

Show all FDA fields
City
Indiana
State
PA
Status
Terminated
Country
United States
Event ID
91980
Address
625 Kolter Dr Ste 4
Code information
Lot #: B1635780-040522, Exp. Date 04/30/2023
Postal code
15701-3571
Report date
Apr 12, 2023
Product type
Drugs
Recall number
D-0497-2023
Classification
Class II
Recalling firm
RemedyRepack Inc.
Product quantity
16 bottles
Termination date
Oct 19, 2023
Reason for recall
cGMP Deviations
Voluntary / mandated
Voluntary: Firm initiated
Product description
Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2972-00
Distribution pattern
RemedyRepack distributed product to consignees nationwide within the United States
Recall initiation date
Mar 20, 2023
Initial firm notification
Letter
Center classification date
Mar 31, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0497-2023, published Apr 12, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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