Why it was recalled
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Product description
Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Hospira, Inc., Lake forest, IL 60045 USA. NDC: 0409-2634-01
Lot numbers, UPCs & expiration codes
Lot 71330DD EXP. 11/1/2018.
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-0597-2018
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Feb 7, 2018
- FDA report date
- Mar 21, 2018
- Quantity
- 29, 680 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-0597-2018, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 79114
- Address
- 235 E 42nd St
- Code information
- Lot 71330DD EXP. 11/1/2018.
- Postal code
- 10017-5703
- Report date
- Mar 21, 2018
- Product type
- Drugs
- Recall number
- D-0597-2018
- Classification
- Class I
- Recalling firm
- Pfizer Inc.
- Product quantity
- 29, 680 vials
- Termination date
- Aug 7, 2019
- Reason for recall
- Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Hospira, Inc., Lake forest, IL 60045 USA. NDC: 0409-2634-01
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Feb 7, 2018
- Initial firm notification
- Letter
- Center classification date
- Mar 14, 2018