Fluocinolone Acetonide Topical Solution recall: Impurity Out of Spec
Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, MD 21202 Manufactured by…
Why was Fluocinolone Acetonide Topical Solution recalled?
Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot# M16666, EXP 12/2018
- Product
- Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, MD 21202 Manufactured by…
- Recalling firm
- LUPIN SOMERSET
- Quantity
- 2712 60-ml bottles
- Distribution
- Nationwide in the USA
- Recall date
- October 31, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)