Class II · Moderate risk
Metronidazole 500mg 100ml
Lack of sterility assurance
Metronidazole Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
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
Metronidazole Injection, USP, 500 mg/100 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-001-24
Affected NDC
36000-0001-24
Compare with the code on your package — it is the most precise check available.
Drug: Metronidazole Category: Antibiotic
- Recalling firm
- Claris Lifesciences Inc
- NDC code
- 36000-001-24
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0616-2017 · 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 Metronidazole recalls
See all
Class II · Moderate risk
Metronidazole tablets
cGMP deviations: Temperature abuse
Class II · Moderate risk
Metronidazole Vaginal Gel USP
cGMP deviations: Temperature abuse
Class II · Moderate risk
Metronidazole 1% Gel
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Reverse Dml Lotion
Lack of Assurance of Sterility: There are also CGMP Deviations.
Other recalls by Claris Lifesciences Inc
All 2017 recalls
Class III · Low risk
Ciprofloxacin in Dextrose
Superpotent
Class II · Moderate risk
Levofloxacin Injection in 5% Dextrose
Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
Class II · Moderate risk
Fluconazole Injection
Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
Class II · Moderate risk
Ciprofloxacin in Dextrose
Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
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