Drug product
Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottles (100-count bottle), Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801, NDC 59746-122-06
D-0767-2022
Product summary
- Event
- Event 89854
- Status
- Terminated
- Classification
- Class I
- Quantity
- 12,174 bottles
- Official record key
drug-enforcement:D-0767-2022
Official wording
Reason: Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets contain bottles incorrectly labeled as PredniSONE Tablets. The tablets in the bottles are Meclizine Hydrochloride
Code information: Lot # 22P0036, Exp 12/2024
Distribution pattern: Product was distributed in Arkansas, Florida, North Carolina, South Carolina and Ohio.
Derived failure modes
-
Labeling or packaging
Labeling: Label mix-up: Incorrect