Class II · Moderate risk
Meropenem
Lack of sterility assurance
Meropenem I.V. 1 g is supplied in 30 mL injection vials
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was 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.
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What 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
Affected NDC
0409-3506-01
Compare with the code on your package — it is the most precise check available.
Drug: Meropenem
- Recalling firm
- Hospira Inc.
- NDC code
- 0409-3506-01
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0303-2015 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Meropenem recalls
See all
Class II · Moderate risk
Meropenem for Injection
Lack of assurance of sterility: loss of container integrity.
Class II · Moderate risk
Meropenem 2 grams in 100 mL 0.9% NS bag
Lack of Sterility Assurance
Class II · Moderate risk
Meropenem 1 g/NS 100 mL Minibag Plus
Lack of Assurance of Sterility
Class II · Moderate risk
MEROPENEM in NS
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Other recalls by Hospira Inc.
All 2014 recalls
Class I · High risk
Infant 25% DEXTROSE Injection
Presence of Particulate Matter: human hair found within an internal sample syringe.
Class II · Moderate risk
Fentanyl Citrate Injection
Lack of Assurance of Sterility: Complaints of broken tips on the ampules.
Class II · Moderate risk
DOBUTamine Injection
Discoloration: Firm received complaints of product discoloration and particulates.
Class III · Low risk
5% Lidocaine HCL and 7.5% Dextrose Injection
Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.
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