Recalls / Class III
Class IIID-0110-2021
Product
Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-010-59
- Affected lot / code info
- Lot #: 14481 Exp 10/31/2021
Why it was recalled
Subpotent Drug: One lot of Triamcinolone Acetonide Lotion, 0.025% 60 mL.does not meet assay results.
Recalling firm
- Firm
- Teligent Pharma, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 105 Lincoln Avenue, N/A, Buena, New Jersey 08310
Distribution
- Quantity
- 4008 units
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2020-11-03
- FDA classified
- 2020-11-25
- Posted by FDA
- 2020-12-02
- Terminated
- 2023-12-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0110-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.