D-0303-2015 Class II Terminated
FDA drug recall D-0303-2015 was initiated by Hospira Inc. on Oct 24, 2014 and is designated Class II. Reason for recall: Defective Container: Glass vials may crack due to low (thin) out of specification vial wall thickness which may lead to contamination and lack of assurance of sterility. The recall status is terminated (terminated Dec 15, 2016). Affected quantity: 261,706 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 24, 2014
- Initiation Date
- Oct 24, 2014
- Termination Date
- Dec 15, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 261,706 vials
Product Description
Meropenem I.V. 1 g is supplied in 30 mL injection vials, RX only. Manufactured by Hospira Healthcare India Pvt. Ltd Tamil Nadu, India for Hospira, Inc. 275 N. Field Drive, Lake Forest, IL 60045. NDC 0409-3506-01
Reason for Recall
Defective Container: Glass vials may crack due to low (thin) out of specification vial wall thickness which may lead to contamination and lack of assurance of sterility.
Distribution Pattern
Nationwide and Puerto Rico, Italy, Netherland, Spain
Code Information
Lot #: 609E014, Exp 1/2016; 609E015, Exp 1J/2016; 609E016, Exp 1/2016; 609E017, Exp 1/2016; 609E018, Exp 1/2016; 609E019, Exp 1/2016; 601E025, Exp 1/2016; 601E027, Exp 1/2016; 601E028A, Exp 1/2016; 601E028B, Exp 1/2016; 601E028C, Exp 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-0303-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026