POLYETHYLENE GLYCOL 3350 Recall D-0875-2022
Description: GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-19
POLYETHYLENE GLYCOL 3350 Recall D-0875-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0875-2022 |
| Event ID | 90094 |
| Brand | GAVILYTE - C |
| Generic Name | POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK |
| Manufacturer | POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK |
| Original Package? | 1 |
| Active Substance | POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE |
| Drug Route | ORAL |
| Distribution | Product was distributed nationwide, including Puerto Rico. |
| Quantity | 26,910 bottles |
| Recall Reason | Failed Stability Specification |
| Drug Classification | Class II |
| Drug Code Info | 20220525 |
| Product NDC | 43386-060 |
| Product NUI | N0000010288 N0000175811 N0000009871 |
| Drug UPC | 0343386060191 0343386204021 |
| Pharma Class (PE) | Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] |
| Pharma Class (EPC) | Osmotic Laxative [EPC] |
| Recall Initiation Date | 20220427 |
| Report Date | 20220525 |
| Classification Date | 20220516 |
| Address | Harborplace Tower111 S Calvert St Fl 21st Baltimore, MD 21202-6174 United States |
| Recalling Firm | Lupin Pharmaceuticals Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | G2M7P15E5P 660YQ98I10 |
| Drug Application Number | ANDA090186 |
| Structured Product Labeling (SPL ID) | 7af81acb-3c86-4089-93dc-2cf9a6fac42a |
| Structured Product Labeling (SPL Set ID) | a8b15625-ca7c-4d57-9f36-3ac2a6d13665 |
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