Recall: D-0767-2022

Class I - Dangerous

Class IClassification

2022-03-08Initiated

TerminatedStatus

Jubilant Cadista PharmaceuticaFirm

Product

Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottles (100-count bottle), Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801, NDC 59746-122-06

Reason

Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets contain bottles incorrectly labeled as PredniSONE Tablets. The tablets in the bottles are Meclizine Hydrochloride

Distribution

Product was distributed in Arkansas, Florida, North Carolina, South Carolina and Ohio.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.