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MECLIZINE HYDROCHLORIDE Recall D-1037-2022

Description: Meclizine Hydrochloride Tablets, USP, 25 mg, 50-count cartons (5 x10 unit dose), 10 Tablets per card, 5 cards per carton, Rx only, MFG: Avkare Inc., NDC 50268-523-15

MECLIZINE HYDROCHLORIDE Recall D-1037-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1037-2022
Event ID89646
BrandMECLIZINE HYDROCHLORIDE
Generic NameMECLIZINE
ManufacturerMECLIZINE
Active SubstanceMECLIZINE HYDROCHLORIDE
Drug RouteORAL
DistributionUSA nationwide.
Quantity1 box/50 blister packs per box
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC50268-522 50268-523
Recall Initiation Date20220413
Report Date20220615
Classification Date20220609
Address9954 Maryland DriveDeep Run Iii Ste. 4000
Richmond, VA 23233
United States
Recalling FirmMckesson Medical-Surgical Inc. Corporate Office
Initial Notification Letter
Unique Ingredient IdentifierHDP7W44CIO
Drug Application NumberANDA201451
Structured Product Labeling (SPL ID)d5de145e-32e5-9e0c-e053-2a95a90a3a60
Structured Product Labeling (SPL Set ID)af5d0c9b-a997-8033-afca-3c04221f2e76
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