FDA-Drug2018-03-21Class I

Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Hospira, Inc., Lake forest, IL 60045 USA. NDC: 0409-2634-01

Pfizer Inc.
Hazard

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

Sold states
Nationwide in the USA
Affected count
29, 680 vials
Manufactured in
235 E 42nd St, New York, NY, United States
Products
Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Hospira, Inc., Lake forest, IL 60045 USA. NDC: 0409-2634-01

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0597-2018

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