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CLOMIPHENE CITRATE Recall D-1041-2022

Description: ClomiPHENE Citrate Tablets, USP 50 mg, 30-count bottle, Rx only, MFG: PAR Pharma, NDC 49884-701-55

CLOMIPHENE CITRATE Recall D-1041-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1041-2022
Event ID89646
BrandCLOMIPHENE CITRATE
Generic NameCLOMIPHENE CITRATE
ManufacturerCLOMIPHENE CITRATE
Original Package?1
Active SubstanceCLOMIPHENE CITRATE
Drug RouteORAL
DistributionUSA nationwide.
Quantity240 cartons/3 blister packs per carton
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC49884-701
Drug UPC0349884701543 0349884701550 0349884701529
Recall Initiation Date20220413
Report Date20220615
Classification Date20220609
Address9954 Maryland DriveDeep Run Iii Ste. 4000
Richmond, VA 23233
United States
Recalling FirmMckesson Medical-Surgical Inc. Corporate Office
Initial Notification Letter
Unique Ingredient Identifier1B8447E7YI
Drug Application NumberANDA075528
Structured Product Labeling (SPL ID)a381820e-898a-4a49-83e6-a243a3d99750
Structured Product Labeling (SPL Set ID)be399623-6400-475d-93d3-1dedd4d43017
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