Drug recall D-0082-2018
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 for recall
Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.
Lots and codes
Lot # 17P0430, Exp 05/19
Recall details
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD
- Quantity
- 744 bottles
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- October 30, 2017
- Terminated
- February 12, 2020
Related products
- Meclizine Hydrochloride – drug information
- NDC 59746-122 Meclizine Hydrochloride · Meclizine Hydrochloride 12.5 mg/1 · Jubilant Cadista Pharmacuticals Inc.
- NDC 59746-121 Meclizine Hydrochloride · Meclizine Hydrochloride 25 mg/1 · Jubilant Cadista Pharmacuticals Inc.