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ORPHENADRINE CITRATE Recall D-0753-2022

Description: Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC 0185-0022-01.

ORPHENADRINE CITRATE Recall D-0753-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0753-2022
Event ID88937
BrandORPHENADRINE CITRATE
Generic NameORPHENADRINE CITRATE
ManufacturerORPHENADRINE CITRATE
Original Package?1
Active SubstanceORPHENADRINE CITRATE
Drug RouteORAL
DistributionNationwide
Quantity7908 bottles(790,800 extended release tablets)
Recall ReasonCGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
Drug ClassificationClass II
Drug Code Info20220413
Product NDC0185-0022
Recall Initiation Date20220321
Report Date20220413
Classification Date20220406
Address506 Carnegie Ctr Ste 400
Princeton, NJ 08540-6243
United States
Recalling FirmSandoz, Inc
Initial Notification Press Release
Unique Ingredient IdentifierX0A40N8I4S
Drug Application NumberANDA040327
Structured Product Labeling (SPL ID)b06a6b24-6a02-4ecf-b43b-ed014f24734f
Structured Product Labeling (SPL Set ID)239018ff-cec6-46de-ae9d-26c9ec034a32
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