Product Safety Recalls

Product Recall Tracker

CARBACHOL Recall D-1036-2022

Description: MIOSTAT (Carbachol Intraocular Solution, USP) 0.01%, 1.5 mL, Rx only, MFG: Alcon Surgical Inc., NDC 0065-0023-15

CARBACHOL Recall D-1036-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1036-2022
Event ID89646
BrandMIOSTAT
Generic NameCARBACHOL
ManufacturerCARBACHOL
Original Package?1
Active SubstanceCARBACHOL
Drug RouteOPHTHALMIC
DistributionUSA nationwide.
Quantity8 boxes/12 vials each
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0065-0023
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 Identifier8Y164V895Y
Drug Application NumberNDA016968
Structured Product Labeling (SPL ID)dc823099-2746-41e7-8da8-d56fc6eafe4d
Structured Product Labeling (SPL Set ID)f28d7a56-e079-4a8b-ad81-9a97c780de67
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