D-0390-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 30, 2019
- Initiation Date
- January 15, 2019
- Termination Date
- February 17, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24,180 bottles
Product Description
Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; NDC 43386-069-60.
Reason for Recall
Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated out of specification results for total impurities that have been chemically identified as oxidative degradation products of the fluocinolone active pharmaceutical ingredient.
Distribution Pattern
Nationwide in the USA and Puerto Rico
Code Information
Lot #: S700214, Exp Apr-19; S700447, Exp Jun-19; S700787, Exp Oct-19; S701057, Exp Nov-19; S800107, Exp Feb-20; S800266, Exp Mar-20; S800524, Exp May-20; S800791, Exp Jul-20