HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride (0.2 mg/mL) Single-Dose Syringe, Rx Only, Ca...

FDA Recall #D-0194-2017 — Class II — November 18, 2016

Recall #D-0194-2017 Date: November 18, 2016 Classification: Class II Status: Terminated

Product Description

HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-002-03

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

2509 syringes

Distribution

Nationwide

Code Information

Lot: 8742

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated