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.

Class I - Dangerous

💊 Drugs Recalled: January 15, 2019 LUPIN SOMERSET Prescription Drugs Nationwide

What Should You Do?

Check if you have this product:
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
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: LUPIN SOMERSET
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.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full 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.

Product Codes/Lot Numbers:

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