Drug Enforcement D-0425-2023

CGMP Deviations: recalling drug products following an FDA inspection.

Status

Terminated

Classification

Class II

Report Date

March 8, 2023

Termination Date

April 22, 2024

Product Information

Product description
rOPINIRole Tablets USP 0.25 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 16729-232-01, UPC 3 16729 23201 2;
Product quantity
139,332 bottles
Reason for recall
CGMP Deviations: recalling drug products following an FDA inspection.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
United States including Puerto Rico and Canada

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-0425-2023
Event ID
91657
Recall initiation date
February 7, 2023
Center classification date
March 2, 2023
Code info
Batches: P2102086, Exp. Date 3/31/2023; P2105094, P2105095, P2105097, P2105096, P2105093, Exp. Date 7/31/2023; P2106490, P2106491, P2106493, P2106492, P2106494, Exp. Date 9/30/2023; P2201069, P2201068, P2201067, Exp. Date 1/31/2024; P2203516, Exp. Date 5/31/2024
More code info
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