FDAFDA · Food and drugs·Recall number D-0082-2018
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
Published November 22, 2017 · Recall initiated: October 30, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- MECLIZINE HYDROCHLORIDE
- Manufacturer
- Jubilant Cadista Pharmaceuticals, Inc.
- Distributor
- Nationwide
- UPC
- 0359746121068
- Lot
- Lot # 17P0430, Exp 05/19
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.