Drug product
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)
D-0250-2021
Product summary
- Event
- Event 87233
- Status
- Terminated
- Classification
- Class III
- Quantity
- 502 cartons
- Official record key
drug-enforcement:D-0250-2021
Official wording
Reason: Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials
Code information: Lot: M2013645 Exp. Aug. 2022
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling; Label Mix-up