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Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial (1 mg/mL), Single-Dose Injection...

FDA Recall #D-0196-2017 — Class II — November 18, 2016

Recall #D-0196-2017 Date: November 18, 2016 Classification: Class II Status: Terminated

Product Description

Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial (1 mg/mL), Single-Dose Injection Solution For Slow IV Use, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-006-10

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

93 vials

Distribution

Nationwide

Code Information

Lot: 163941

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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