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Class II: temporary or reversible health riskTerminated

Wilshire Pharmaceuticals Meclizine HCl Tablets Recall

Meclizine HCl Tablets, USP, 25 mg, 100 Tablets bottles, Rx Only, Mfd

Wilshire Pharmaceuticals Inc · Atlanta, GA

Risk level
Class II
Reported by FDA
Feb 24, 2021
Recall ID
D-0259-2021
Check your lot numberHow we source this data

Summary

Wilshire Pharmaceuticals recalled Meclizine HCl Tablets starting Feb 4, 2021. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0259-2021 on Feb 24, 2021. Reason: Failed Dissolution Specifications. Status: Terminated.

Why it was recalled

Failed Dissolution Specifications

Product description

Meclizine HCl Tablets, USP, 25 mg, 100 Tablets bottles, Rx Only, Mfd. for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328, Product of India, NDC 52536-133-01

Lot numbers, UPCs & expiration codes

Lot #: 18030329, 18030330, 18030331, Exp 03/2021.

Where it was sold

FL, TX

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-0259-2021
Classification
Class II
Status
Terminated
Recall initiated
Feb 4, 2021
FDA report date
Feb 24, 2021
Quantity
35928 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Wilshire Pharmaceuticals Inc

Original FDA data

Every field from FDA enforcement report D-0259-2021, exactly as published.

Show all FDA fields
City
Atlanta
State
GA
Status
Terminated
Country
United States
Event ID
87268
Address
6 Concourse Pkwy NE
Code information
Lot #: 18030329, 18030330, 18030331, Exp 03/2021.
Postal code
30328-6117
Report date
Feb 24, 2021
Product type
Drugs
Recall number
D-0259-2021
Classification
Class II
Recalling firm
Wilshire Pharmaceuticals Inc
Product quantity
35928 bottles
Termination date
Jun 2, 2023
Reason for recall
Failed Dissolution Specifications
Voluntary / mandated
Voluntary: Firm initiated
Product description
Meclizine HCl Tablets, USP, 25 mg, 100 Tablets bottles, Rx Only, Mfd. for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328, Product of India, NDC 52536-133-01
Distribution pattern
FL, TX
Recall initiation date
Feb 4, 2021
Initial firm notification
Letter
Center classification date
Feb 16, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0259-2021, published Feb 24, 2021. 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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