PlainRecalls
FDA Drug Moderate Class II Terminated

Hydromorphone Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Single Dose Vial.(10 vials per carton NDC 0703-0113-01) and 180 vials per case (NDC 0703-0113-03) Mfd By: Hospira, Inc., Lake Forest, IL 60045 USA, Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618 USA.

Reported: August 16, 2017 Initiated: July 26, 2017 #D-1082-2017

Product Description

Hydromorphone Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Single Dose Vial.(10 vials per carton NDC 0703-0113-01) and 180 vials per case (NDC 0703-0113-03) Mfd By: Hospira, Inc., Lake Forest, IL 60045 USA, Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618 USA.

Reason for Recall

Presence of Particulate Matter: Silicone oil

Details

Recalling Firm
HOSPIRA INC, LAKE FOREST
Units Affected
56,340 vials
Distribution
Nationwide in the USA
Location
LAKE FOREST, IL

Frequently Asked Questions

What product was recalled?
Hydromorphone Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Single Dose Vial.(10 vials per carton NDC 0703-0113-01) and 180 vials per case (NDC 0703-0113-03) Mfd By: Hospira, Inc., Lake Forest, IL 60045 USA, Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618 USA.. Recalled by HOSPIRA INC, LAKE FOREST. Units affected: 56,340 vials.
Why was this product recalled?
Presence of Particulate Matter: Silicone oil
Which agency issued this recall?
This recall was issued by the FDA Drug on August 16, 2017. Severity: Moderate. Recall number: D-1082-2017.