Product Safety Recalls

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MECLIZINE HYDROCHLORIDE Recall D-0767-2022

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

MECLIZINE HYDROCHLORIDE Recall D-0767-2022 Information

StatusCompleted
Mandated?Voluntary: Firm initiated
Recall NumberD-0767-2022
Event ID89854
BrandMECLIZINE HYDROCHLORIDE
Generic NameMECLIZINE HYDROCLORIDE
ManufacturerMECLIZINE HYDROCLORIDE
Original Package?1
Active SubstanceMECLIZINE HYDROCHLORIDE
Drug RouteORAL
DistributionProduct was distributed in Arkansas, Florida, North Carolina, South Carolina and Ohio.
Quantity12,174 bottles
Recall ReasonLabeling: 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
Drug ClassificationClass I
Drug Code Info20220406
Product NDC59746-121 59746-122
Drug UPC0359746121068 0359746122065
Recall Initiation Date20220308
Report Date20220406
Classification Date20220412
Address207 Kiley Dr
Salisbury, MD 21801-2249
United States
Recalling FirmJubilant Cadista Pharmaceuticals, Inc.
Initial Notification E-Mail
Unique Ingredient IdentifierHDP7W44CIO
Drug Application NumberANDA040659
Structured Product Labeling (SPL ID)9fbce799-a4af-48b2-95c8-4f5bcb5a5833
Structured Product Labeling (SPL Set ID)9350fefc-9c00-182c-c3a9-044d4a40856f
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