D-0168-2023 Class II Terminated
FDA drug recall D-0168-2023 was initiated by Accord Healthcare, Inc. on January 12, 2023 and is designated Class II. Reason for recall: Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet. The recall status is terminated (terminated April 23, 2024). Affected quantity: 87,576 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 1, 2023
- Initiation Date
- January 12, 2023
- Termination Date
- April 23, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 87,576 bottles
Product 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
Reason for Recall
Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.
Distribution Pattern
Nationwide in the USA
Code Information
Lots: R2200455, R2200456 Exp. 03/2025