HYDROCODONE BITARTRATE Recall D-0276-2022
Description: Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Manufactured by: Ascent Pharmaceuticals, Inc., Central Islip, NY 11722, NDC 31722-997-01.
HYDROCODONE BITARTRATE Recall D-0276-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0276-2022 |
| Event ID | 89060 |
| Brand | HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
| Generic Name | HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
| Manufacturer | HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
| Original Package? | 1 |
| Active Substance | HYDROCODONE BITARTRATE ACETAMINOPHEN |
| Drug Route | ORAL |
| Distribution | USA Nationwide |
| Quantity | 9744 bottles |
| Recall Reason | Product Mix-up |
| Drug Classification | Class II |
| Drug Code Info | 20211215 |
| Product NDC | 31722-996 31722-997 |
| Drug UPC | 0331722996013 0331722997010 |
| Recall Initiation Date | 20211119 |
| Report Date | 20211215 |
| Classification Date | 20211207 |
| Address | 400 S Technology Dr Central Islip, NY 11722-4402 United States |
| Recalling Firm | Ascent Pharmaceuticals, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 362O9ITL9D NO70W886KK |
| Drug Application Number | ANDA211487 |
| Structured Product Labeling (SPL ID) | 96c2ac12-9186-41d7-9575-fa9386688307 |
| Structured Product Labeling (SPL Set ID) | ed6af366-753c-4f3b-a6a2-c9a183c50035 |
| Similar To |