Drug recall D-0397-2023
Product
Glycopyrrolate Injection, USP, 0.4 mg/2 mL (0.2 mg/mL) 2 mL Single Dose Vial X 25 vials carton, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA 2 ML vial NDC 16729-472-30 UPC 3 16729 47230 2; carton NDC 16729-472-08 UPC 3 16729 47208 1
Reason for recall
CGMP Deviations: recalling drug products following an FDA inspection.
Lots and codes
Batches: R2200509, Exp. Date 4/30/2024, R2200507, Exp. Date 4/30/2024, R2200508, Exp. Date 4/30/2024
Recall details
- Recalling firm
- Accord Healthcare, Inc., Durham, NC
- Quantity
- 5,273 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.,