Glycopyrrolate 1 mg/5 mL (0.2 mg/mL) Injection Solution, 5 mL Single-Dose Syringe, For IV Use, Ho...
FDA Recall #D-0191-2017 — Class II — November 18, 2016
Product Description
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
Reason for Recall
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Recalling Firm
Cantrell Drug Company — Little Rock, AR
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
48,592 syringes
Distribution
Nationwide
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated