Class II · Moderate risk
Meropenem
Lack of sterility assurance
Meropenem for Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of assurance of sterility: loss of container integrity.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Meropenem for Injection, USA (I.V.), 1 gram/vial, 25 vials per carton, Sterile, Rx Only, Manufactured for: Hospira, Inc., Lake Forest, IL 60045, USA. NDC carton: 0409-3506-01; NDC vial: 0409-3506-11
Affected NDCs
0409-3506-01
0409-3506-11
Compare with the code on your package — it is the most precise check available.
Drug: Meropenem
- Recalling firm
- Pfizer Inc.
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0095-2019 · 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 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.
Class II · Moderate risk
Meropenem various strengths in normal saline bags
Lack of sterility assurance.
Other recalls by Pfizer Inc.
All 2018 recalls
Class II · Moderate risk
Dopamine HCl Inj.
Lack of Assurance of Sterility
Class II · Moderate risk
Vial Label: 8.4% Sodium Bicarbonate Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Vial Label: Epinephrine Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Levoxyl (levothyroxine sodium tablets, USP)
Subpotent drug
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