Why it was recalled
Presence of Particulate Matter: Silicone oil
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
Lot numbers, UPCs & expiration codes
Lot #: 560053F, Exp. 01AUG2017
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1080-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 26, 2017
- FDA report date
- Aug 16, 2017
- Quantity
- 14,300 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- HOSPIRA INC, LAKE FOREST
Original FDA data
Every field from FDA enforcement report D-1080-2017, exactly as published.
Show all FDA fields
- City
- LAKE FOREST
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 77836
- Address
- 275 NORTH FOREST DRIVE
- Code information
- Lot #: 560053F, Exp. 01AUG2017
- Postal code
- 60045
- Report date
- Aug 16, 2017
- Product type
- Drugs
- Recall number
- D-1080-2017
- Classification
- Class II
- Recalling firm
- HOSPIRA INC, LAKE FOREST
- Product quantity
- 14,300 vials
- Termination date
- May 11, 2018
- Reason for recall
- Presence of Particulate Matter: Silicone oil
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jul 26, 2017
- Initial firm notification
- Telephone
- Center classification date
- Aug 9, 2017