Drug product
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
D-0653-2017
Product summary
- Event
- Event 76231
- Status
- Terminated
- Classification
- Class III
- Quantity
- 7,656 bottles
- Official record key
drug-enforcement:D-0653-2017
Official wording
Reason: Chemical Contamination
Code information: Lot # M15496; Exp. 10/17 Lot # M15507; Exp. 12/17
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Chemical Contamination