Reported Aug 8, 2018 · Terminated
Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 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, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only
- Manufactured forClaris Lifesciences Inc., North Brunswick, NJ 08902
- ByClaris Injectables Ltd., Gujarat, India, NDC a) 36000-002-10 and b) 36000-002-06
- Lot codes and dates
Lot #: a) A060966A060967A060965A061023Exp 07/18b) A060962Exp 02/19
- Amount recalled
- 12088 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: lots out of specification for elevated sodium chloride and fluconazole assay.
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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