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ESZOPICLONE Recall D-1174-2022

Description: Eszopiclone Tablets, USP 1 mg, packaged in 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, INDIA, NDC 33342-299-07

ESZOPICLONE Recall D-1174-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1174-2022
Event ID90444
BrandESZOPICLONE
Generic NameESZOPICLONE
ManufacturerESZOPICLONE
Original Package?1
Active SubstanceESZOPICLONE
Drug RouteORAL
DistributionDistributed Nationwide and Puerto Rico.
Quantity168690 Tablets
Recall ReasonShortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
Drug ClassificationClass II
Drug Code Info20220713
Product NDC33342-299 33342-300 33342-301
Drug UPC0333342299079 0333342300119 0333342301116
Recall Initiation Date20220616
Report Date20220713
Classification Date20220705
Address666 Plainsboro Rd Bldg 200 Ste 230
Plainsboro, NJ 08536-0009
United States
Recalling FirmMacleods Pharma Usa Inc
Initial Notification Letter
Unique Ingredient IdentifierUZX80K71OE
Drug Application NumberANDA202929
Structured Product Labeling (SPL ID)29150821-8963-45fd-879d-535ca7d6b19b
Structured Product Labeling (SPL Set ID)12593790-e72f-45b1-8895-987cdd075134
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