Class II
Terminated
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
- Company
- Lupin Somerset
- Recall Initiated
- October 5, 2018
- Posted
- October 31, 2018
- Recall Number
- D-0092-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2712 60-ml bottles
- Firm Location
- Somerset, NJ, United States
Reason for Recall
Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis
Distribution
Nationwide in the USA
Lot / Code Info
Lot# M16666, EXP 12/2018
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