Reported Dec 27, 2017 · Terminated
Fluconazole Injection, USP, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 mL (NDC 33600-002-10), Rx Only,…
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, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 mL (NDC 33600-002-10), Rx Only
- Manufactured forClaris LifeSciences, Inc. North Brunswick
- NJ 08902 ByClaris Injectables Ltd., Gujarat, India
- Lot codes and dates
a) A060174 01/13/2018A060257 02/28/2018A060692 05/31/2018A061165 09/30/2018A0A0143 01/31/2019A0A0347 03/31/2019and A0A0424 04/30/2019b) A060027 12/31/2017
- Amount recalled
- 24,569 bags
Where it was sold
- Nationwide
Why it was recalled
Superpotent
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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