D-0082-2018 Class III Terminated
FDA drug recall D-0082-2018 was initiated by Jubilant Cadista Pharmaceuticals, Inc. on October 30, 2017 and is designated Class III. Reason for recall: Marketed without an approved NDA/ANDA: Bottles were released prior to final approval. The recall status is terminated (terminated February 12, 2020). Affected quantity: 744 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- November 22, 2017
- Initiation Date
- October 30, 2017
- Termination Date
- February 12, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 744 bottles
Product Description
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.
Distribution Pattern
Nationwide
Code Information
Lot # 17P0430, Exp 05/19