Drug Enforcement D-0168-2023

Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.

Status

Terminated

Classification

Class II

Report Date

February 1, 2023

Termination Date

April 23, 2024

Product Information

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
Product quantity
87,576 bottles
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.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
ACCORD HEALTHCARE, INC.
Address
1009 Slater Rd Ste 210B, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0168-2023
Event ID
91499
Recall initiation date
January 12, 2023
Center classification date
January 20, 2023
Code info
Lots: R2200455, R2200456 Exp. 03/2025
More code info
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