Why it was recalled
Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability testing
Product description
Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g), Rx Only, Teligent Pharma Inc., Buena, NJ, 08310, NDC 52565-023-29
Lot numbers, UPCs & expiration codes
Lot # 16569, Exp 9/2022
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-0297-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 23, 2021
- FDA report date
- Jan 5, 2022
- Quantity
- 3,792 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teligent Pharma, Inc.
Original FDA data
Every field from FDA enforcement report D-0297-2022, exactly as published.
Show all FDA fields
- City
- Buena
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 88550
- Address
- 105 Lincoln Avenue
- Code information
- Lot # 16569, Exp 9/2022
- Postal code
- 08310
- Report date
- Jan 5, 2022
- Product type
- Drugs
- Recall number
- D-0297-2022
- Classification
- Class II
- Recalling firm
- Teligent Pharma, Inc.
- Product quantity
- 3,792 bottles
- Termination date
- Aug 16, 2024
- Reason for recall
- Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability testing
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g), Rx Only, Teligent Pharma Inc., Buena, NJ, 08310, NDC 52565-023-29
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Aug 23, 2021
- Initial firm notification
- Letter
- Center classification date
- Dec 28, 2021