Recalls / Class III
Class IIID-0119-2021
Product
Clobetasol Propionate Ointment USP 0.05%, Net Wt. 50 grams, Rx Only, Teligent Pharma. Inc. Buena, NJ 08310 NDC 52565-039-60
- Affected lot / code info
- Lot Number: 12597, exp. date 12/2020
Why it was recalled
Superpotent and Subpotent; low and high 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
- 20160 tubes
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2020-11-05
- FDA classified
- 2020-12-08
- Posted by FDA
- 2020-12-09
- Terminated
- 2024-08-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0119-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.