Why it was recalled
Presence of Foreign Substance: Foreign particles observed during routine stability testing.
Product description
Diflorasone Diacetate Ointment USP, 0.05%, packaged in a)15 g (NDC 52565-063-15) and b) 30 g (NDC 52565-063-30) tubes, Rx only, Manufactured by: Teligent Pharma, Inc, Buena, NJ 08310.
Lot numbers, UPCs & expiration codes
Lot #: 16264, Exp Date Nov 2022
Where it was sold
Nationwide in 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-0636-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 14, 2021
- FDA report date
- Jun 30, 2021
- Quantity
- 6,240 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teligent Pharma, Inc.
Original FDA data
Every field from FDA enforcement report D-0636-2021, exactly as published.
Show all FDA fields
- City
- Buena
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 87950
- Address
- 105 Lincoln Avenue
- Code information
- Lot #: 16264, Exp Date Nov 2022
- Postal code
- 08310
- Report date
- Jun 30, 2021
- Product type
- Drugs
- Recall number
- D-0636-2021
- Classification
- Class II
- Recalling firm
- Teligent Pharma, Inc.
- Product quantity
- 6,240 tubes
- Termination date
- Aug 22, 2022
- Reason for recall
- Presence of Foreign Substance: Foreign particles observed during routine stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Diflorasone Diacetate Ointment USP, 0.05%, packaged in a)15 g (NDC 52565-063-15) and b) 30 g (NDC 52565-063-30) tubes, Rx only, Manufactured by: Teligent Pharma, Inc, Buena, NJ 08310.
- Distribution pattern
- Nationwide in the United States
- Recall initiation date
- May 14, 2021
- Initial firm notification
- Letter
- Center classification date
- Jun 23, 2021