Recalls / Class III
Class IIID-1391-2019
Product
Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented), a) 15 gram (NDC 52565-019-15) and b) 50 gram (NDC 52565-019-51) tubed, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 06310
- Affected lot / code info
- Lot 11852, exp date 08/2020
Why it was recalled
Failed Impurities/Degradation Specifications
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
- 9360 tubes
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2019-05-20
- FDA classified
- 2019-06-14
- Posted by FDA
- 2019-06-26
- Terminated
- 2025-01-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1391-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.