Drug Enforcement D-0429-2023

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 3 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 16729-236-01, UPC 3 16729 23601 0
Product quantity
14,928 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-0429-2023
Event ID
91657
Recall initiation date
February 7, 2023
Center classification date
March 2, 2023
Code info
Batches: P2105099, P2105098, Exp. Date 7/31/2023, P2106507, P2106508, P2106510, P2106509, Exp. Date 9/30/2023, P2202750, Exp. Date 4/30/2024
More code info
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