October 2021 FDA Recall Cetirizine by A-s Medication Solutions Llc.
D-0096-2022 - Labeling
This Class III drug recall was voluntarily initiated by A-s Medication Solutions Llc. on October 5, 2021 for the product Cetirizine. The FDA reported the reason for recall as labeling. The product was distributed in FL, IN, MN, WI and the recall is currently terminated.
Recall Number: D-0096-2022
Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it was a manufacturer in a box with 30 tablet count tablets.
10-05-2021
11-17-2021
72 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
A-S Medication Solutions LLC.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
FL, IN, MN, WI
08-12-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Cetirizine hydrochloride, 10 mg tablets, 90-count bottle, Distributed by: A-S Medications Solutions, Libertyville, IL 60048, Mfg: Major Pharmaceuticals, Livonia, MI 48152, NDC: 50090-5510-3
Batch or Lot Expiration Information
Lot# : 1256330
