Drug 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
D-0092-2019
Product summary
- Firm
- LUPIN SOMERSET
- Event
- Event 81168
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2712 60-ml bottles
- Official record key
drug-enforcement:D-0092-2019
Official wording
Reason: Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis
Code information: Lot# M16666, EXP 12/2018
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of specification