Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: Rising Pharma Holdings, Inc. East Bruns
Summary
The FDA issued a Class II for Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: by RISING PHARMACEUTICALS. Reason: Labeling: Incorrect Instructions.
Details
Source
Drug Recall
External ID
D-0005-2022
Action Date
2021-10-13
Status
Ongoing
Category
drug
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/Code Info: Lot # CB21024, Exp 2/2023
Quantity Affected: 1,344 bottles
Reason for Recall
Labeling: Incorrect Instructions
Distribution
to be entered
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-02
Company
East Brunswick, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 85 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
RISING PHARMACEUTICALS has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (RISING PHARMACEUTICALS) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does RISING PHARMACEUTICALS have FDA actions?
RISING PHARMACEUTICALS has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0005-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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