Hydromorphone recalled over sterility concerns

Recall date

February 7, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Pfizer Inc. recalls Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. M…

Recall number

D-0596-2018

FDA classification

Class I

Brand / firm

Pfizer Inc.

Sold / distributed

Nationwide in the USA

Why it was recalled

Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618. NDC: 0703-0110-01