Why it was recalled
Failed Impurities/Degradation Specifications:
Product description
Flurandrenolide Ointment USP, 0.05%, Net Wt. 60 grams, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310 NDC 52565-017-60
Lot numbers, UPCs & expiration codes
Lot #13974 EXP 7/2021
Where it was sold
Distributed 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-0356-2021
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 9, 2021
- FDA report date
- Apr 28, 2021
- Quantity
- 3432 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teligent Pharma, Inc.
Original FDA data
Every field from FDA enforcement report D-0356-2021, exactly as published.
Show all FDA fields
- City
- Buena
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 87694
- Address
- 105 Lincoln Avenue
- Code information
- Lot #13974 EXP 7/2021
- Postal code
- 08310
- Report date
- Apr 28, 2021
- Product type
- Drugs
- Recall number
- D-0356-2021
- Classification
- Class II
- Recalling firm
- Teligent Pharma, Inc.
- Product quantity
- 3432 tubes
- Reason for recall
- Failed Impurities/Degradation Specifications:
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Flurandrenolide Ointment USP, 0.05%, Net Wt. 60 grams, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310 NDC 52565-017-60
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Apr 9, 2021
- Initial firm notification
- Letter
- Center classification date
- Apr 28, 2021