Product Safety Recalls

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ANHYDROUS CITRIC ACID Recall D-1085-2022

Description: E-Z-Gas II, Effervescent Granules, Net Weight: 4 g, 50 packets per box, MFG: Bracco Diagnostics Inc., NDC 0270-9020-01 (discontinued), NDC 10361-793-01 (current)

ANHYDROUS CITRIC ACID Recall D-1085-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1085-2022
Event ID89646
BrandE-Z-GAS
Generic NameANTACID/ANTIFLATULENT
ManufacturerANTACID/ANTIFLATULENT
Original Package?1
Active SubstanceANHYDROUS CITRIC ACID DIMETHICONE
Drug RouteORAL
DistributionUSA nationwide.
Quantity16 boxes/50 pouches per box
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC10361-793
Product NUIN0000175833 N0000175835 N0000175980
Pharma Class (PE)Decreased Coagulation Factor Activity [PE]
Pharma Class (EPC)Calculi Dissolution Agent [EPC]
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 IdentifierXF417D3PSL 92RU3N3Y1O
Drug Application Numberpart331
Structured Product Labeling (SPL ID)697c1a8a-02fa-43a3-9ba0-a76e1278dd0a
Structured Product Labeling (SPL Set ID)4e12e1cb-b033-076d-e054-00144ff8d46c
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