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DILTIAZEM HYDROCHLORIDE Recall D-1302-2022

Description: Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 180 mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA; NDC 52544-691-30.

DILTIAZEM HYDROCHLORIDE Recall D-1302-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1302-2022
Event ID90635
BrandMATZIM LA
Generic NameDILTIAZEM HYDROCHLORIDE
ManufacturerDILTIAZEM HYDROCHLORIDE
Original Package?1
Active SubstanceDILTIAZEM HYDROCHLORIDE
Drug RouteORAL
DistributionNationwide in the USA and Puerto Rico
Quantity8022 bottles
Recall ReasonFailed Dissolution Specifications: below specification limits for dissolution.
Drug ClassificationClass II
Drug Code Info20220810
Product NDC52544-691 52544-692 52544-693
Recall Initiation Date20220721
Report Date20220810
Classification Date20220804
Address400 Interpace Pkwy Bldg A
Parsippany, NJ 07054-1120
United States
Recalling FirmTeva Pharmaceuticals USA Inc
Unique Ingredient IdentifierOLH94387TE
Drug Application NumberANDA077686
Structured Product Labeling (SPL ID)69b750fd-ab07-4051-891d-d091e5edbbc2
Structured Product Labeling (SPL Set ID)e8c8dd18-9d95-4068-9762-bec1eb1bc25c
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