AMOXICILLIN Recall D-1025-2022
Description: Amoxicillin Capsules, USP, 500 mg, 100-count bottle, Rx only, MFG: Sandoz Pharma, NDC 0781-2613-01
AMOXICILLIN Recall D-1025-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1025-2022 |
| Event ID | 89646 |
| Brand | AMOXICILLIN |
| Generic Name | AMOXICILLIN |
| Manufacturer | AMOXICILLIN |
| Original Package? | 1 |
| Active Substance | AMOXICILLIN |
| Drug Route | ORAL |
| Distribution | USA nationwide. |
| Quantity | 12 bottles |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 0781-2020 0781-2613 0781-5060 |
| Drug UPC | 0307812613016 0307812020012 0307815060015 |
| 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 | 804826J2HU |
| Drug Application Number | ANDA064076 |
| Structured Product Labeling (SPL ID) | f314ad63-2023-476e-a211-f9cef3be8e2c |
| Structured Product Labeling (SPL Set ID) | 13bd4214-9b7f-425b-af5f-fc1ddc678230 |
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