Why it was recalled
Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated out of specification results for total impurities that have been chemically identified as oxidative degradation products of the fluocinolone active pharmaceutical ingredient.
Product description
Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; NDC 43386-069-60.
Lot numbers, UPCs & expiration codes
Lot #: S700214, Exp Apr-19; S700447, Exp Jun-19; S700787, Exp Oct-19; S701057, Exp Nov-19; S800107, Exp Feb-20; S800266, Exp Mar-20; S800524, Exp May-20; S800791, Exp Jul-20
Where it was sold
Nationwide in the USA and Puerto Rico
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-0390-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 15, 2019
- FDA report date
- Jan 30, 2019
- Quantity
- 24,180 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- LUPIN SOMERSET
Original FDA data
Every field from FDA enforcement report D-0390-2019, exactly as published.
Show all FDA fields
- City
- Somerset
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 81925
- Address
- 400 Campus Dr
- Code information
- Lot #: S700214, Exp Apr-19; S700447, Exp Jun-19; S700787, Exp Oct-19; S701057, Exp Nov-19; S800107, Exp Feb-20; S800266, Exp Mar-20; S800524, Exp May-20; S800791, Exp Jul-20
- Postal code
- 08873-1145
- Report date
- Jan 30, 2019
- Product type
- Drugs
- Recall number
- D-0390-2019
- Classification
- Class II
- Recalling firm
- LUPIN SOMERSET
- Product quantity
- 24,180 bottles
- Termination date
- Feb 17, 2023
- Reason for recall
- Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated out of specification results for total impurities that have been chemically identified as oxidative degradation products of the fluocinolone active pharmaceutical ingredient.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; NDC 43386-069-60.
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Jan 15, 2019
- Initial firm notification
- Letter
- Center classification date
- Jan 23, 2019