D-0597-2018 Class I Terminated
FDA drug recall D-0597-2018 was initiated by Pfizer Inc. on Feb 7, 2018 and is designated Class I. Reason for recall: Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked. The recall status is terminated (terminated Aug 7, 2019). Affected quantity: 29, 680 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 21, 2018
- Initiation Date
- Feb 7, 2018
- Termination Date
- Aug 7, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29, 680 vials
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
Reason for Recall
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Distribution Pattern
Nationwide in the USA
Code Information
Lot 71330DD EXP. 11/1/2018.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0597-2018
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026