FDA-Drug2018-03-21Class I

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

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
53600 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. Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618. NDC: 0703-0110-01

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0596-2018

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief