D-0044-2015 Class II Terminated
FDA drug recall D-0044-2015 was initiated by Hospira Inc. on Oct 1, 2014 and is designated Class II. Reason for recall: Lack Of Assurance Of Sterility: Confirmed customer complaints of glass product container vials that may be broken or cracked. The recall status is terminated (terminated Mar 23, 2017). Affected quantity: 145,600 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 29, 2014
- Initiation Date
- Oct 1, 2014
- Termination Date
- Mar 23, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 145,600 vials
Product Description
Hydromorphone Hydrochloride Injection, USP, 10 mg/mL, Rx only, packaged in a) 1 mL Single-dose Vial (NDC 0703-0110-01), packaged in 10 x 1 mL Single-dose Vials per carton (NDC 0703-0110-03); Mfd By: Hospira Inc., Lake Forest, IL 60045; Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618; and b) 1 mL Single-dose Vial, packaged in 10 x 1 mL Single-dose Vials per carton (NDC 0409-2634-01), Hospira, Inc., Lake Forest, IL 60045.
Reason for Recall
Lack Of Assurance Of Sterility: Confirmed customer complaints of glass product container vials that may be broken or cracked.
Distribution Pattern
Nationwide
Code Information
Lot #: a) 260753F, 261403F, Exp 1FEB2015; 290153F, Exp 1MAY2015; b) 24-080-DD, Exp 1DEC2014; 25-475-DD, Exp 1JAN2015
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0044-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026