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
Reported: April 19, 2017 Initiated: February 22, 2017 #D-0653-2017
Product Description
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
Reason for Recall
Chemical Contamination
Details
- Recalling Firm
- Novel Laboratories, Inc.
- Units Affected
- 7,656 bottles
- Distribution
- Nationwide
- Location
- Somerset, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Novel Laboratories, Inc.. Units affected: 7,656 bottles.
Why was this product recalled? ▼
Chemical Contamination
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 19, 2017. Severity: Low. Recall number: D-0653-2017.
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