Drug 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
D-0082-2018
Product summary
- Event
- Event 78461
- Status
- Terminated
- Classification
- Class III
- Quantity
- 744 bottles
- Official record key
drug-enforcement:D-0082-2018
Official wording
Reason: Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.
Code information: Lot # 17P0430, Exp 05/19
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.