Drug recall D-0398-2023
Product
Glycopyrrolate Injection, USP 1 mg/5 mL (0.2 mg/mL) 5 mL Multiple Dose Vial, x 10 vials carton, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA 5mL vial NDC 16729-473-31 UPC 3 16729 47331 6; carton NDC 16729-473-03 UPC 3 16729 47303 3
Reason for recall
CGMP Deviations: recalling drug products following an FDA inspection.
Lots and codes
Batches: R2200259, Exp. Date 2/29/2024, R2200258, Exp. Date 2/29/2024, R2200617, Exp. Date 4/30/2024, R2201308, Exp. Date 8/31/2024
Recall details
- Recalling firm
- Accord Healthcare, Inc., Durham, NC
- Quantity
- 3,164 vials
- Distribution
- United States including Puerto Rico and Canada
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 7, 2023
- Terminated
- April 22, 2024
Related products
- Glycopyrrolate – drug information
- NDC 16729-474 Glycopyrrolate · Glycopyrrolate .2 mg/mL · Accord Healthcare, Inc.,
- NDC 16729-471 Glycopyrrolate · Glycopyrrolate .2 mg/mL · Accord Healthcare, Inc.,
- NDC 16729-473 Glycopyrrolate · Glycopyrrolate .2 mg/mL · Accord Healthcare, Inc.,
- NDC 16729-472 Glycopyrrolate · Glycopyrrolate .2 mg/mL · Accord Healthcare, Inc.,