Why it was recalled
Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
Product description
Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-704-86
Lot numbers, UPCs & expiration codes
Lot #: 07040001A, exp. date 02/2022
Where it was sold
Product was distributed nationwide within the United States
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-0233-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 4, 2021
- FDA report date
- Nov 24, 2021
- Quantity
- 7,766 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amneal Pharmaceuticals of New York, LLC
Original FDA data
Every field from FDA enforcement report D-0233-2022, exactly as published.
Show all FDA fields
- City
- Brookhaven
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 88997
- Address
- 50 Horseblock Rd
- Code information
- Lot #: 07040001A, exp. date 02/2022
- Postal code
- 11719-9509
- Report date
- Nov 24, 2021
- Product type
- Drugs
- Recall number
- D-0233-2022
- Classification
- Class II
- Recalling firm
- Amneal Pharmaceuticals of New York, LLC
- Product quantity
- 7,766 bottles
- Termination date
- Jun 9, 2022
- Reason for recall
- Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-704-86
- Distribution pattern
- Product was distributed nationwide within the United States
- Recall initiation date
- Nov 4, 2021
- Initial firm notification
- Letter
- Center classification date
- Nov 16, 2021