Product Safety Recalls

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CLONIDINE Recall D-1152-2022

Description: Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches (NDC 51862-455-01) per Carton (51862-455-04), Rx only, Manufactured for: Mayne Pharma Greenville, NC 27834

CLONIDINE Recall D-1152-2022 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-1152-2022
Event ID90406
Original Package?1
Active SubstanceCLONIDINE
DistributionNationwide in the US Market
Quantity1440 cartons
Recall ReasonDefective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.
Drug ClassificationClass II
Drug Code Info20220629
Product NDC51862-453 51862-454 51862-455
Product NUIN0000009918 N0000175554
Pharma Class (EPC)Central alpha-2 Adrenergic Agonist [EPC]
Recall Initiation Date20220609
Report Date20220629
Classification Date20220621
Address1240 Sugg Pkwy
Greenville, NC 27834-9006
United States
Recalling FirmMayne Pharma Inc
Initial Notification Letter
Unique Ingredient IdentifierMN3L5RMN02
Drug Application NumberANDA079090
Structured Product Labeling (SPL ID)d876b634-0405-4ace-b85d-27191bb0b1fc
Structured Product Labeling (SPL Set ID)c41eb913-5e47-46c4-9d96-9a67f8380919
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