Drug Enforcement D-0427-2023

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 1 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 16729-234-01, UPC 3 16729 23401 6
Product quantity
104,945 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-0427-2023
Event ID
91657
Recall initiation date
February 7, 2023
Center classification date
March 2, 2023
Code info
Batches: P2103544 Exp. Date 5/31/2023, P2106132, P2106131, P2106128, P2106129, P2106130, P2106133, Exp. Date 8/31/2023, P2107662, P2107663, P2107664, Exp. Date 11/30/2023, P2203543, Exp. Date 5/31/2024
More code info
—