Recalls / Class II
Class IID-0258-2022
Product
Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc., Buena, New Jersey, 08310, NDC 52565-002-05
- Affected lot / code info
- Lot #: 15188, Exp 2/2023
Why it was recalled
Defective Container
Recalling firm
- Firm
- Teligent Pharma, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 105 Lincoln Avenue, Buena, New Jersey 08310
Distribution
- Quantity
- 2664 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2021-10-19
- FDA classified
- 2021-11-23
- Posted by FDA
- 2021-12-01
- Terminated
- 2024-06-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0258-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.