Drug product
Glycopyrrolate 1 mg/5 mL (0.2 mg/mL) Injection Solution, 5 mL Single-Dose Syringe, For IV Use, Hospital/Office Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207, NDC 52533-028-15
D-0191-2017
Product summary
- Event
- Event 75745
- Status
- Terminated
- Classification
- Class II
- Quantity
- 48,592 syringes
- Official record key
drug-enforcement:D-0191-2017
Official wording
Reason: Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Code information: Lot: 9006 BUD: 1/20/2017, Lot: 8757 BUD: 11/30/2016, Lot: 8954 BUD: 1/6/2017, Lot: 9174 BUD: 2/20/2017
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility