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
Reported: March 8, 2023 Initiated: February 7, 2023 #D-0399-2023
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
Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Details
- Recalling Firm
- Accord Healthcare, Inc.
- Units Affected
- 322 vials
- Distribution
- United States including Puerto Rico and Canada
- Location
- Durham, NC
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Accord Healthcare, Inc.. Units affected: 322 vials.
Why was this product recalled? ▼
CGMP Deviations: recalling drug products following an FDA inspection.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 8, 2023. Severity: Moderate. Recall number: D-0399-2023.
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