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Class II: temporary or reversible health riskOngoing

Rising Pharmaceuticals Meclizine HCl Tablets Recall

Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: Rising…

RISING PHARMACEUTICALS · East Brunswick, NJ

Risk level
Class II
Reported by FDA
Oct 13, 2021
Recall ID
D-0005-2022
Check your lot numberHow we source this data

Summary

Rising Pharmaceuticals recalled Meclizine HCl Tablets starting Sep 2, 2021. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0005-2022 on Oct 13, 2021. Reason: Labeling: Incorrect Instructions. Status: Ongoing.

Why it was recalled

Labeling: Incorrect Instructions

Product description

Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816, Manufactured by: Aurex laboratories LLC, East Windsor, NJ 08520, NDC 16571-752-01

Lot numbers, UPCs & expiration codes

Lot # CB21024, Exp 2/2023

Where it was sold

to be entered

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-0005-2022
Classification
Class II
Status
Ongoing
Recall initiated
Sep 2, 2021
FDA report date
Oct 13, 2021
Quantity
1,344 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
RISING PHARMACEUTICALS

Original FDA data

Every field from FDA enforcement report D-0005-2022, exactly as published.

Show all FDA fields
City
East Brunswick
State
NJ
Status
Ongoing
Country
United States
Event ID
88593
Address
2 Tower Center Blvd
Code information
Lot # CB21024, Exp 2/2023
Postal code
08816-1100
Report date
Oct 13, 2021
Product type
Drugs
Recall number
D-0005-2022
Classification
Class II
Recalling firm
RISING PHARMACEUTICALS
Product quantity
1,344 bottles
Reason for recall
Labeling: Incorrect Instructions
Voluntary / mandated
Voluntary: Firm initiated
Product description
Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816, Manufactured by: Aurex laboratories LLC, East Windsor, NJ 08520, NDC 16571-752-01
Distribution pattern
to be entered
Recall initiation date
Sep 2, 2021
Initial firm notification
Letter
Center classification date
Oct 7, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0005-2022, published Oct 13, 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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