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PANTOPRAZOLE SODIUM Recall D-0852-2022

Description: Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets per bottle, Manufactured by: Torrent Pharmaceuticals Ltd., Indrad-382 721, India, Manufactured for: Torrent Pharma Inc., Levittown, PA 19057, NDC# 13668-096-90.

PANTOPRAZOLE SODIUM Recall D-0852-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0852-2022
Event ID89992
BrandPANTOPRAZOLE SODIUM
Generic NamePANTOPRAZOLE SODIUM
ManufacturerPANTOPRAZOLE SODIUM
Original Package?1
Active SubstancePANTOPRAZOLE SODIUM
Drug RouteORAL
DistributionNationwide in the U.S.A
Quantity24,888 bottles
Recall ReasonCGMP deviations: tablets cracking
Drug ClassificationClass II
Drug Code Info20220511
Product NDC13668-096 13668-429
Drug UPC0313668429305 0313668096309
Recall Initiation Date20220411
Report Date20220511
Classification Date20220505
Address2091 Hartel Ave
Levittown, PA 19057-4506
United States
Recalling FirmTorrent Pharma Inc
Initial Notification Letter
Unique Ingredient Identifier6871619Q5X
Drug Application NumberANDA090074
Structured Product Labeling (SPL ID)c2dde4e5-88b0-436e-a89c-c8854ae0b686
Structured Product Labeling (SPL Set ID)9c983da1-a8e0-479e-8816-5d5668ea242e
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