ALLOPURINOL Recall D-0168-2023
Description: Allopurinol Tablets USP, 100 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India. NDC 16729-134-01
ALLOPURINOL Recall D-0168-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0168-2023 |
| Event ID | 91499 |
| Brand | ALLOPURINOL |
| Generic Name | ALLOPURINOL |
| Manufacturer | ALLOPURINOL |
| Original Package? | 1 |
| Active Substance | ALLOPURINOL |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA |
| Quantity | 87,576 bottles |
| Recall Reason | Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet. |
| Drug Classification | Class II |
| Drug Code Info | 20230201 |
| Product NDC | 16729-134 16729-135 |
| Product NUI | N0000175698 N0000000206 |
| Pharma Class (EPC) | Xanthine Oxidase Inhibitor [EPC] |
| Recall Initiation Date | 20230112 |
| Report Date | 20230201 |
| Classification Date | 20230120 |
| Address | 1009 Slater Rd Ste 210B Durham, NC 27703-8446 United States |
| Recalling Firm | Accord Healthcare, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 63CZ7GJN5I |
| Drug Application Number | ANDA203154 |
| Structured Product Labeling (SPL ID) | d10d00c1-a0d9-6fd8-e053-2a95a90a588a |
| Structured Product Labeling (SPL Set ID) | 682dd8b8-fc6e-47c5-95b7-82d7ad96b750 |
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