Drug recall D-0653-2017
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
Reason for recall
Chemical Contamination
Lots and codes
Lot # M15496; Exp. 10/17 Lot # M15507; Exp. 12/17
Recall details
- Recalling firm
- Novel Laboratories, Inc., Somerset, NJ
- Quantity
- 7,656 bottles
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 22, 2017
- Terminated
- August 19, 2019
Related products
- Fluocinolone Acetonide – drug information
- NDC 43386-069 Fluocinolone Acetonide · Fluocinolone Acetonide .1 mg/mL · Lupin Pharmaceuticals,Inc.