Reported Aug 8, 2018 · Terminated
Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 200 mL (2 mg/mL), 200 mL Single Dose…
Renaissance Lakewood, LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Renaissance Lakewood, LLC · 1200 Paco Way · Lakewood, NJ · 08701-5938
Is this the product you have?
Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 200 mL (2 mg/mL), 200 mL Single Dose Flexible Container bag, Rx only, Manufactured for
3 of 3 products
| # | Product as published |
|---|---|
| 1 | Claris Lifesciences Inc., North Brunswick, NJ 08902 |
| 2 | By: Claris Injectables Ltd., Gujarat, India |
| 3 | NDC 36000-003-06. |
- Lot codes and dates
Lot # A061213Exp 09/18
- Amount recalled
- 3000 bags
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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