Recalls / Class II
Class IID-0396-2023
Product
Glycopyrrolate Injection, USP, 0.2 mg/mL, 1 mL Single Dose Vial x 25 vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA 1 ml vial NDC 16729-471-63 UPC 3 16729 47163 3; 25 x 1 mL carton NDC 16729-471-08 UPC 3 16729 47108 4
- Brand name
- Glycopyrrolate
- Generic name
- Glycopyrrolate
- Active ingredient
- Glycopyrrolate
- Route
- Intramuscular, Intravenous
- NDCs
- 16729-471, 16729-472, 16729-473, 16729-474
- FDA application
- ANDA213238
- Affected lot / code info
- Batches: R2200436, Exp. Date 1/31/2024, R2200159, Exp. Date 1/31/2024, R2200166, Exp. Date 1/31/2024, R2200618, Exp. Date 4/30/2024, R2201290, Exp. Date 8/31/2024, R2201324, Exp. Date 8/31/2024
Why it was recalled
CGMP Deviations: recalling drug products following an FDA inspection.
Recalling firm
- Firm
- Accord Healthcare, Inc.
- Manufacturer
- Accord Healthcare, Inc.,
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1009 Slater Rd Ste 210B, N/A, Durham, North Carolina 27703-8446
Distribution
- Quantity
- 23,814 vials
- Distribution pattern
- United States including Puerto Rico and Canada
Timeline
- Recall initiated
- 2023-02-07
- FDA classified
- 2023-03-02
- Posted by FDA
- 2023-03-08
- Terminated
- 2024-04-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0396-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.