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Recall Observatory FDA recall evidence

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

October 24, 2014

Class II

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

    reason.potency_specification_failure · v1.0.0

    out of specification
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    lack of assurance of sterility