Class II
Terminated
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
This recall has been terminated (originally issued December 24, 2014).
- Company
- Hospira Inc.
- Recall Initiated
- October 24, 2014
- Posted
- December 24, 2014
- Recall Number
- D-0303-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 261,706 vials
- Firm Location
- Lake Forest, IL, United States
- Official Source
- View on FDA website ↗
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
Nationwide and Puerto Rico, Italy, Netherland, Spain
Lot / Code Info
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
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