Recalls / Class II
Class IID-0390-2019
Product
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.
- Brand name
- Fluocinolone Acetonide
- Generic name
- Fluocinolone Acetonide
- Active ingredient
- Fluocinolone Acetonide
- Route
- Topical
- NDC
- 43386-069
- FDA application
- ANDA206422
- Affected 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
Why it was recalled
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.
Recalling firm
- Firm
- LUPIN SOMERSET
- Manufacturer
- Lupin Pharmaceuticals,Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Campus Dr, N/A, Somerset, New Jersey 08873-1145
Distribution
- Quantity
- 24,180 bottles
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2019-01-15
- FDA classified
- 2019-01-23
- Posted by FDA
- 2019-01-30
- Terminated
- 2023-02-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0390-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.