Recalls / Class II
Class IID-1082-2017
Product
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.
- Brand name
- Hydromorphone Hydrochloride
- Generic name
- Hydromorphone Hydrochloride
- Active ingredient
- Hydromorphone Hydrochloride
- Route
- Intramuscular, Intravenous, Subcutaneous
- NDCs
- 0703-0018, 0703-0110, 0703-0113
- FDA application
- ANDA078591
- Affected lot / code info
- Lot #: 560103F, Exp. 01AUG2017
Why it was recalled
Presence of Particulate Matter: Silicone oil
Recalling firm
- Firm
- HOSPIRA INC, LAKE FOREST
- Manufacturer
- Teva Parenteral Medicines, Inc.
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 275 NORTH FOREST DRIVE, N/A, LAKE FOREST, Illinois 60045
Distribution
- Quantity
- 56,340 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2017-07-26
- FDA classified
- 2017-08-09
- Posted by FDA
- 2017-08-16
- Terminated
- 2018-05-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1082-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.