D-1080-2017 Class II Terminated

Recalled by HOSPIRA INC, LAKE FOREST — LAKE FOREST, IL

FDA drug recall D-1080-2017 was initiated by HOSPIRA INC, LAKE FOREST on Jul 26, 2017 and is designated Class II. Reason for recall: Presence of Particulate Matter: Silicone oil The recall status is terminated (terminated May 11, 2018). Affected quantity: 14,300 vials.

Recall details

Product Type
Drugs
Report Date
Aug 16, 2017
Initiation Date
Jul 26, 2017
Termination Date
May 11, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
14,300 vials

Product description

Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial. Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618 USA. NDC: 0703-0018-01

Reason for recall

Presence of Particulate Matter: Silicone oil

Distribution pattern

Nationwide in the USA

Code information

Lot #: 560053F, Exp. 01AUG2017

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-1080-2017
openFDA file date
Nov 10, 2026
Loaded by RegDataLab
Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Source: openFDA record for D-1080-2017. Report a data issue: hello@regdatalab.com.