Why it was recalled
Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
Product description
Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southbridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-996-15
Lot numbers, UPCs & expiration codes
Lot #: 15644, Exp 5/2022
Where it was sold
USA 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-0340-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 2, 2021
- FDA report date
- May 5, 2021
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teligent Pharma, Inc.
Original FDA data
Every field from FDA enforcement report D-0340-2021, exactly as published.
Show all FDA fields
- City
- Buena
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 87266
- Address
- 105 Lincoln Avenue
- Code information
- Lot #: 15644, Exp 5/2022
- Postal code
- 08310
- Report date
- May 5, 2021
- Product type
- Drugs
- Recall number
- D-0340-2021
- Classification
- Class III
- Recalling firm
- Teligent Pharma, Inc.
- Termination date
- Aug 15, 2024
- Reason for recall
- Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southbridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-996-15
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Feb 2, 2021
- Initial firm notification
- Letter
- Center classification date
- Apr 23, 2021