Accord Healthcare, Inc.: Drug Recall

Recall #D-0399-2023 · 02/07/2023

Class II: Risk

Recall Details

Recall Number
D-0399-2023
Classification
Class II
Product Type
Drug
Recalling Firm
Accord Healthcare, Inc.
Status
Terminated
Date Initiated
02/07/2023
Location
Durham, NC, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
322 vials

Reason for Recall

CGMP Deviations: recalling drug products following an FDA inspection.

Product Description

Glycopyrrolate Injection, USP 4 mg/20 mL (0.2 mg/mL) 20 mL Multiple Dose Vial, 10vial carton, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA 20mL vial NDC 16729-474-05 UPC 3 16729 47405 4;carton NDC 16729-474-03 UPC 3 16729 47403 0

Distribution Pattern

United States including Puerto Rico and Canada

Other Recalls by Accord Healthcare, Inc.

View all recalls by Accord Healthcare, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.