Why it was recalled
Subpotent Drug: One lot of Triamcinolone Acetonide Lotion, 0.025% 60 mL.does not meet assay results.
Product description
Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-010-59
Lot numbers, UPCs & expiration codes
Lot #: 14481 Exp 10/31/2021
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-0110-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 3, 2020
- FDA report date
- Dec 2, 2020
- Quantity
- 4008 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teligent Pharma, Inc.
Original FDA data
Every field from FDA enforcement report D-0110-2021, exactly as published.
Show all FDA fields
- City
- Buena
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 86705
- Address
- 105 Lincoln Avenue
- Code information
- Lot #: 14481 Exp 10/31/2021
- Postal code
- 08310
- Report date
- Dec 2, 2020
- Product type
- Drugs
- Recall number
- D-0110-2021
- Classification
- Class III
- Recalling firm
- Teligent Pharma, Inc.
- Product quantity
- 4008 units
- Termination date
- Dec 21, 2023
- Reason for recall
- Subpotent Drug: One lot of Triamcinolone Acetonide Lotion, 0.025% 60 mL.does not meet assay results.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-010-59
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Nov 3, 2020
- Initial firm notification
- Letter
- Center classification date
- Nov 25, 2020