Why it was recalled
Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis
Product description
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
Lot numbers, UPCs & expiration codes
Lot# M16666, EXP 12/2018
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0092-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 5, 2018
- FDA report date
- Oct 31, 2018
- Quantity
- 2712 60-ml bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- LUPIN SOMERSET
Original FDA data
Every field from FDA enforcement report D-0092-2019, exactly as published.
Show all FDA fields
- City
- Somerset
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 81168
- Address
- 400 Campus Dr
- Code information
- Lot# M16666, EXP 12/2018
- Postal code
- 08873-1145
- Report date
- Oct 31, 2018
- Product type
- Drugs
- Recall number
- D-0092-2019
- Classification
- Class II
- Recalling firm
- LUPIN SOMERSET
- Product quantity
- 2712 60-ml bottles
- Termination date
- Nov 8, 2022
- Reason for recall
- Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Oct 5, 2018
- Initial firm notification
- Letter
- Center classification date
- Oct 24, 2018