D-0653-2017 Class III Terminated
FDA drug recall D-0653-2017 was initiated by Novel Laboratories, Inc. on February 22, 2017 and is designated Class III. Reason for recall: Chemical Contamination The recall status is terminated (terminated August 19, 2019). Affected quantity: 7,656 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- April 19, 2017
- Initiation Date
- February 22, 2017
- Termination Date
- August 19, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,656 bottles
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
Distribution Pattern
Nationwide
Code Information
Lot # M15496; Exp. 10/17 Lot # M15507; Exp. 12/17