Neostigmine Methylsulfate 5 mg/5 mL Injection Solution, 5 mL (1 mg/mL) Single-Dose Syringe, For S...

FDA Recall #D-0200-2017 — Class II — November 18, 2016

Recall #D-0200-2017 Date: November 18, 2016 Classification: Class II Status: Terminated

Product Description

Neostigmine Methylsulfate 5 mg/5 mL Injection Solution, 5 mL (1 mg/mL) Single-Dose Syringe, For Slow IV Use, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207, NDC 52533-046-15

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

24,547 syringes

Distribution

Nationwide

Code Information

Lot: 8997 BUD: 12/1/2016, Lot: 9246 BUD: 1/23/2017

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated