FDA Drug recall D-0168-2023
Allopurinol Tablets USP, 100 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: I…
- FDA Drug
- Class II
- terminated
- Published 2023-02-01
On 2023-02-01 the FDA classified a Class II recall of Allopurinol Tablets USP, 100 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: I… by Accord Healthcare, citing presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0168-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-01-12 |
| Published | 2023-02-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Accord Healthcare |
| Distribution | US |
Product
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
Reason
Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.
Identifiers
| ndc | 16729-134-10 |
|---|---|
| ndc | 16729-134-01 |
| ndc | 16729-134-16 |
| ndc | 16729-134-17 |
| ndc | 16729-135-10 |
| ndc | 16729-135-01 |
| ndc | 16729-135-16 |
| ndc | 16729-135-17 |
| code_info | Lots: R2200455, R2200456 Exp. 03/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0168-2023%22
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