September 2021 FDA Recall Drug by Rising Pharmaceuticals
D-0005-2022 - Labeling

This Class II drug recall was voluntarily initiated by Rising Pharmaceuticals on September 2, 2021 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in to be entered and the recall is currently ongoing.

Recall Number: D-0005-2022

Reason for Recall
Labeling: Incorrect Instructions
Initiated
09-02-2021
Reported
10-13-2021
Quantity
1,344 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88593
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
RISING PHARMACEUTICALS
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
to be entered
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# CB21024, Exp 2/2023