Product Safety Recalls

Product Recall Tracker

NITROGLYCERIN Recall D-1049-2022

Description: Nitrostat (Nitroglycerin Sublingual Tablets, USP) 0.4 mg/tablet, 25-count bottle, Rx only, Distributed by: Pfizer Parke-Davis, Division of Pfizer Inc., NDC 0071-0418-13

NITROGLYCERIN Recall D-1049-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1049-2022
Event ID89646
BrandNITROSTAT
Generic NameNITROGLYCERIN
ManufacturerNITROGLYCERIN
Original Package?1
Active SubstanceNITROGLYCERIN
Drug RouteSUBLINGUAL
DistributionUSA nationwide.
Quantity1 carton/4 bottles per carton/25 tablets per bottle
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0071-0417 0071-0418 0071-0419
Product NUIN0000175415 M0014874 N0000009909
Drug UPC0300710417243 0300710419247
Pharma Class (PE)Vasodilation [PE]
Pharma Class (EPC)Nitrate Vasodilator [EPC]
Pharma Class (CS)Nitrates [CS]
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 IdentifierG59M7S0WS3
Drug Application NumberNDA021134
Structured Product Labeling (SPL ID)b21bdc0d-86ca-4a5f-9695-a7a8064f5bed
Structured Product Labeling (SPL Set ID)79ba021e-183c-4b4d-822e-4ff5ef54ca61
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