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
Reported: December 24, 2014 Initiated: October 24, 2014 #D-0303-2015
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.
Details
- Recalling Firm
- Hospira Inc.
- Units Affected
- 261,706 vials
- Distribution
- Nationwide and Puerto Rico, Italy, Netherland, Spain
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Hospira Inc.. Units affected: 261,706 vials.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 24, 2014. Severity: Moderate. Recall number: D-0303-2015.
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