Drug product
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
D-0303-2015
Product summary
- Firm
- Hospira Inc.
- Event
- Event 69798
- Status
- Terminated
- Classification
- Class II
- Quantity
- 261,706 vials
- Official record key
drug-enforcement:D-0303-2015
Official wording
Reason: 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.
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
Distribution pattern: Nationwide and Puerto Rico, Italy, Netherland, Spain
Derived failure modes
-
Potency or specification failure
out of specification
-
Sterility assurance
lack of assurance of sterility