Why it was recalled
Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.
Product description
Fluocinonide Ointment USP 0.05%, packaged in: a) 15 gm tube, NDC 52565-0040-15, b) 30 gm tube, NDC 52565-0040-30 c) 60 gram tube, NDC 52565-0040-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310
Lot numbers, UPCs & expiration codes
Lot#: a) 12250, Exp 10/2020; 15039, Exp 1/2022; 15573, Exp 7/2022; b) 12250, Exp 10/2020; 14589, 14848, Exp 12/2021; 15039, Exp 1/2022; 15245, Exp 2/2022; c) 12241, 12249, Exp 10/2020; 14222, Exp 8/2021; 15039, Exp 1/2022; 15037, 15246, Exp 2/2022; 15340, Exp 3/2022; 15387, Exp 4/2022
Where it was sold
United States Nationwide
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-0064-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 28, 2020
- FDA report date
- Nov 11, 2020
- Quantity
- 36,790 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teligent Pharma, Inc.
Original FDA data
Every field from FDA enforcement report D-0064-2021, exactly as published.
Show all FDA fields
- City
- Buena
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 86508
- Address
- 105 Lincoln Avenue
- Code information
- Lot#: a) 12250, Exp 10/2020; 15039, Exp 1/2022; 15573, Exp 7/2022; b) 12250, Exp 10/2020; 14589, 14848, Exp 12/2021; 15039, Exp 1/2022; 15245, Exp 2/2022; c) 12241, 12249, Exp 10/2020; 14222, Exp 8/2021; 15039, Exp 1/2022; 15037, 15246, Exp 2/2022; 15340, Exp 3/2022; 15387, Exp 4/2022
- Postal code
- 08310
- Report date
- Nov 11, 2020
- Product type
- Drugs
- Recall number
- D-0064-2021
- Classification
- Class III
- Recalling firm
- Teligent Pharma, Inc.
- Product quantity
- 36,790 tubes
- Termination date
- Aug 22, 2022
- Reason for recall
- Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Fluocinonide Ointment USP 0.05%, packaged in: a) 15 gm tube, NDC 52565-0040-15, b) 30 gm tube, NDC 52565-0040-30 c) 60 gram tube, NDC 52565-0040-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310
- Distribution pattern
- United States Nationwide
- Recall initiation date
- Sep 28, 2020
- Initial firm notification
- Letter
- Center classification date
- Nov 5, 2020