Why it was recalled
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Product description
Betamethasone Dipropionate Lotion USP, 0.05%* (Augmented), packaged in a) 30 mL (29 grams) bottles, NDC 52565-023-29; b) 60 mL (58 grams) bottles, NDC 52565-023-59, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310
Lot numbers, UPCs & expiration codes
Batch: a) 15998, Exp. 3/31/2022; b) 16104, Exp. 4/30/2022; 16133, Exp. 5/31/2022; 16391, Exp. 8/31/2022; 15440, Exp. 9/30/2022
Where it was sold
Nationwide in the USA and Puerto Rico
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-0669-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 15, 2022
- FDA report date
- Mar 30, 2022
- Quantity
- 43,218 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teligent Pharma, Inc.
Original FDA data
Every field from FDA enforcement report D-0669-2022, exactly as published.
Show all FDA fields
- City
- Buena
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 89798
- Address
- 105 Lincoln Avenue
- Code information
- Batch: a) 15998, Exp. 3/31/2022; b) 16104, Exp. 4/30/2022; 16133, Exp. 5/31/2022; 16391, Exp. 8/31/2022; 15440, Exp. 9/30/2022
- Postal code
- 08310
- Report date
- Mar 30, 2022
- Product type
- Drugs
- Recall number
- D-0669-2022
- Classification
- Class II
- Recalling firm
- Teligent Pharma, Inc.
- Product quantity
- 43,218 bottles
- Termination date
- Jun 17, 2024
- Reason for recall
- cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Betamethasone Dipropionate Lotion USP, 0.05%* (Augmented), packaged in a) 30 mL (29 grams) bottles, NDC 52565-023-29; b) 60 mL (58 grams) bottles, NDC 52565-023-59, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Mar 15, 2022
- Initial firm notification
- Letter
- Center classification date
- Mar 21, 2022