D-0767-2022 Class I Terminated
FDA drug recall D-0767-2022 was initiated by Jubilant Cadista Pharmaceuticals, Inc. on March 8, 2022 and is designated Class I. Reason for recall: 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 a… The recall status is terminated (terminated November 15, 2022). Affected quantity: 12,174 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- April 6, 2022
- Initiation Date
- March 8, 2022
- Termination Date
- November 15, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,174 bottles
Product Description
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
Reason for Recall
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
Distribution Pattern
Product was distributed in Arkansas, Florida, North Carolina, South Carolina and Ohio.
Code Information
Lot # 22P0036, Exp 12/2024