FDA Recall D-0597-2018
Pfizer Inc. · New York, NY
Class I — life-threatening Terminated 546 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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
Reason for recall
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Recall record
- Recall number
D-0597-2018- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA
- Recall initiated
- 2018-02-07
- Classified by FDA Center
- 2018-03-14
- FDA published
- 2018-03-21
- Terminated
- 2019-08-07
- Recalling firm
- Pfizer Inc.
- Firm location
- New York, NY
Drug identification
- Brand name(s)
- HYDROMORPHONE HYDROCHLORIDE
- Generic name(s)
- HYDROMORPHONE HYDROCHLORIDE
- Manufacturer(s)
- Hospira, Inc.
- NDC(s)
0409-2634- Route(s)
- INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS