FDA recall D-0096-2022

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

Reason for recall

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.

Distribution

FL, IN, MN, WI

Key facts

Status

Terminated

Initiation date

2021-10-05

Report date

2021-11-17

Termination date

2022-08-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Libertyville, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0096-2022