D-1082-2017 Class II Terminated
FDA drug recall D-1082-2017 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: 56,340 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
- 56,340 vials
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
Distribution pattern
Nationwide in the USA
Code information
Lot #: 560103F, 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-1082-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026