Recall: D-0399-2023

Class II - Potentially Harmful

Class IIClassification

2023-02-07Initiated

TerminatedStatus

Accord Healthcare, Inc.Firm

Product

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

Reason

CGMP Deviations: recalling drug products following an FDA inspection.

Distribution

United States including Puerto Rico and Canada

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.