Reported Apr 19, 2017 · Terminated
Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmic Use, 60 mL bottle, Rx Only,…
Novel Laboratories, Inc.
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: Novel Laboratories, Inc. · 390 & 400 Campus Drive · Somerset, NJ · 08873-1145
Is this the product you have?
- Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmic Use, 60 mL bottle, Rx Only, Manufactured for Gavis Pharmaceuticals, LLC, Somerset NJ 08873, Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, NDC 43386-069-60
- Lot codes and dates
Lot # M15496Exp. 10/17 Lot # M15507Exp. 12/17
- Amount recalled
- 7,656 bottles
Where it was sold
- Nationwide
Why it was recalled
Chemical Contamination
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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