Product Safety Recalls

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SUMATRIPTAN SUCCINATE Recall D-1111-2022

Description: Sumatriptan Succinate Tablets, 100 mg, 9 (1 x 9) Unit-of- use tablets box, Rx only, MFG: Sun Pharmaceuticals, NDC 62756-522-69

SUMATRIPTAN SUCCINATE Recall D-1111-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1111-2022
Event ID89646
BrandSUMATRIPTAN SUCCINATE
Generic NameSUMATRIPTAN SUCCINATE
ManufacturerSUMATRIPTAN SUCCINATE
Original Package?1
Active SubstanceSUMATRIPTAN SUCCINATE
Drug RouteORAL
DistributionUSA nationwide.
Quantity1 carton/9 blister packs
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC62756-520 62756-521 62756-522
Drug UPC0362756521889 0362756522886 0362756520882
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 IdentifierJ8BDZ68989
Drug Application NumberANDA078295
Structured Product Labeling (SPL ID)22ae72f3-2648-46ae-928f-f158ed0bcf27
Structured Product Labeling (SPL Set ID)9485cc30-15e8-4b53-876d-db317145474b
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