Glycopyrrolate Injection Solution, 1 mL 0.2 mg/1 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Can...

FDA Recall #D-1067-2017 — Class II — July 14, 2017

Recall #D-1067-2017 Date: July 14, 2017 Classification: Class II Status: Terminated

Product Description

Glycopyrrolate Injection Solution, 1 mL 0.2 mg/1 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222; NDC 52533-028-45

Reason for Recall

Lack of Sterility Assurance.

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

5245 syringes

Distribution

Nationwide within the US

Code Information

Lot #: 9868, BUD: 8/9/2017; 9872, BUD: 8/10/2017; 10318, BUD: 10/7/2017

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated