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ANAGRELIDE HYDROCHLORIDE Recall D-0992-2022

Description: Anagrelide Capsules USP, 0.5 mg, 100-count bottles, Rx Only, Manufactured in India For: TEVA PHARMACEUTICALS USA, Inc., North Wales, PA 19454. NDC 0172-5241-60.

ANAGRELIDE HYDROCHLORIDE Recall D-0992-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0992-2022
Event ID90182
BrandANAGRELIDE HYDROCHLORIDE
Generic NameANAGRELIDE HYDROCHLORIDE
ManufacturerANAGRELIDE HYDROCHLORIDE
Original Package?1
Active SubstanceANAGRELIDE HYDROCHLORIDE
Drug RouteORAL
DistributionDistributed Nationwide in the USA
Quantity4224 cartons
Recall ReasonFailed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing.
Drug ClassificationClass I
Drug Code Info20220608
Product NDC0172-5240 0172-5241
Drug UPC0301725240604 0301725241601
Recall Initiation Date20220511
Report Date20220608
Classification Date20220608
Address400 Interpace Pkwy Bldg A
Parsippany, NJ 07054-1120
United States
Recalling FirmTeva Pharmaceuticals USA Inc
Initial Notification Letter
Unique Ingredient IdentifierYTM763Y5C8
Drug Application NumberANDA076468
Structured Product Labeling (SPL ID)fc800314-47d7-41ca-af8a-9222fbf5631c
Structured Product Labeling (SPL Set ID)6727d5d4-e8ec-4a85-bc82-ec70b641eecf
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