Recalls / Class II
Class IID-0092-2019
Product
Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, 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# M16666, EXP 12/2018
Why it was recalled
Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis
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
- 2712 60-ml bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-10-05
- FDA classified
- 2018-10-24
- Posted by FDA
- 2018-10-31
- Terminated
- 2022-11-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0092-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.