Recall: D-0082-2018

Class III - Minor Violations

Class IIIClassification

2017-10-30Initiated

TerminatedStatus

Jubilant Cadista PharmaceuticaFirm

Product

Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-122-06

Reason

Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.

Distribution

Nationwide

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