Drug 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
D-0168-2023
Product summary
- Event
- Event 91499
- Status
- Terminated
- Classification
- Class II
- Quantity
- 87,576 bottles
- Official record key
drug-enforcement:D-0168-2023
Official wording
Reason: Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.
Code information: Lots: R2200455, R2200456 Exp. 03/2025
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance