D-0250-2021 Class III Terminated
FDA drug recall D-0250-2021 was initiated by Accord Healthcare, Inc. on January 28, 2021 and is designated Class III. Reason for recall: Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials The recall status is terminated (terminated February 8, 2022). Affected quantity: 502 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- February 17, 2021
- Initiation Date
- January 28, 2021
- Termination Date
- February 8, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 502 cartons
Product Description
Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose Vials Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad-382 210, India NDC 16729-472-08 (Vial NDC 16729-472-30)
Reason for Recall
Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials
Distribution Pattern
Nationwide
Code Information
Lot: M2013645 Exp. Aug. 2022