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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1085-2022 |
| Event ID | 89646 |
| Brand | E-Z-GAS |
| Generic Name | ANTACID/ANTIFLATULENT |
| Manufacturer | ANTACID/ANTIFLATULENT |
| Original Package? | 1 |
| Active Substance | ANHYDROUS CITRIC ACID DIMETHICONE |
| Drug Route | ORAL |
| Distribution | USA nationwide. |
| Quantity | 16 boxes/50 pouches per box |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 10361-793 |
| Product NUI | N0000175833 N0000175835 N0000175980 |
| Pharma Class (PE) | Decreased Coagulation Factor Activity [PE] |
| Pharma Class (EPC) | Calculi Dissolution Agent [EPC] |
| Recall Initiation Date | 20220413 |
| Report Date | 20220615 |
| Classification Date | 20220609 |
| Address | 9954 Maryland DriveDeep Run Iii Ste. 4000 Richmond, VA 23233 United States |
| Recalling Firm | Mckesson Medical-Surgical Inc. Corporate Office |
| Initial Notification | Letter |
| Unique Ingredient Identifier | XF417D3PSL 92RU3N3Y1O |
| Drug Application Number | part331 |
| 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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