D-0418-2015 Class II Terminated
FDA drug recall D-0418-2015 was initiated by Hospira Inc. on Aug 20, 2015 and is designated Class II. Reason for recall: Defective Container: There were customer complaints of cracked and leaking glass vials. The recall status is terminated (terminated Apr 3, 2017). Affected quantity: 83,320 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 23, 2015
- Initiation Date
- Aug 20, 2015
- Termination Date
- Apr 3, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 83,320 vials
Product Description
Ketamine Hydrochloride Injection, USP (100 mg/mL) packaged in 5 mL multi-dose glass fliptop vials, 10 vials per box, Rx only, Manufactured by: Hospira Inc., Lake Forest, IL 60045. NDC 00409-2051-05
Reason for Recall
Defective Container: There were customer complaints of cracked and leaking glass vials.
Distribution Pattern
Nationwide
Code Information
Lot #s: 43406DD, Exp 7/1/2016; 44255DD, Exp 8/1/2016
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0418-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026