Class II
Terminated
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.
- Company
- Lupin Somerset
- Recall Initiated
- January 15, 2019
- Posted
- January 30, 2019
- Recall Number
- D-0390-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 24,180 bottles
- Firm Location
- Somerset, NJ, United States
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
Nationwide in the USA and Puerto Rico
Lot / Code Info
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
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