Jubilant Cadista Pharmaceuticals, Inc.: Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottles (100-count bottle), Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals, I

Is my product affected?

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

• Brand MECLIZINE HYDROCHLORIDE

Check against the official notice below — it lists the full affected range.

What happened

Jubilant Cadista Pharmaceuticals is recalling Meclizine Hydrochloride Tablets USP, 12.5 mg (Lot # 22P0036, expiring 12/2024) due to a labeling mix-up. Shipper cases labeled as containing Meclizine Hydrochloride actually contain bottles incorrectly labeled as PredniSONE Tablets, even though the tablets inside are the correct Meclizine Hydrochloride product. The recall affects 12,174 bottles that were distributed in Arkansas, Florida, North Carolina, South Carolina, and Ohio.

The source document does not specify what actions affected consumers should take regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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: Product was distributed in Arkansas, Florida, North Carolina, South Carolina and Ohio. Quantity: 12,174 bottles Lot/code info: Lot # 22P0036, Exp 12/2024

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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