The Recall Desk
SevereFDA (Drugs)·D-0303-2015·Announced 2014-12-24

Hospira Recalls Meropenem I.V. Vials Due to Defective Glass

Hospira Inc. is recalling Meropenem I.V. 1 g vials because thin glass walls may crack, leading to contamination and sterility issues.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of contamination and loss of sterility in an injectable medication, which aligns with the 'Severe' criteria for significant injury reports or high-risk defects.

Plain-English summary

Hospira Inc. is recalling Meropenem I.V. 1 g injection vials (NDC 0409-3506-01) due to a defect in the glass vials. The vials have out-of-specification wall thickness that is too thin, which may cause them to crack. This defect may lead to contamination and a lack of assurance of sterility.

The recall affects 261,706 vials distributed nationwide, in Puerto Rico, Italy, the Netherlands, and Spain. Specific lots include 609E014 through 609E019 and 601E025 through 601E028C, all with expiration dates in January 2016.

Healthcare providers and patients should stop using the affected vials and contact Hospira Inc. for further instructions.

The recalled product

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
Manufacturer
Hospira Inc.
Affected units
261,706

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (13)

  • Lot #: 609E014
  • Exp 1/2016
  • 609E015
  • Exp 1J/2016
  • 609E016
  • 609E017
  • 609E018
  • 609E019
  • 601E025
  • 601E027
  • 601E028A
  • 601E028B
  • 601E028C

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically: