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PROMETHAZINE HYDROCHLORIDE Recall D-1057-2022

Description: Promethazine HCl Tablets, USP, 25 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-6461-61

PROMETHAZINE HYDROCHLORIDE Recall D-1057-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1057-2022
Event ID89646
BrandPROMETHAZINE HYDROCHLORIDE
Generic NamePROMETHAZINE HYDROCHLORIDE
ManufacturerPROMETHAZINE HYDROCHLORIDE
Active SubstancePROMETHAZINE HYDROCHLORIDE
Drug RouteORAL
DistributionUSA nationwide.
Quantity16 cartons/100 blisters packs per carton
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0904-6461
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 IdentifierR61ZEH7I1I
Drug Application NumberANDA084176
Structured Product Labeling (SPL ID)85e0d628-0315-4ea2-b604-2b86a31ac2ce
Structured Product Labeling (SPL Set ID)3936f9fe-0bb8-447f-aa7f-1ddb0126f3ab
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