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 70512-025-05.
FDA recall notice · announced December 1, 2021 · Teligent Pharma
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The 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 70512-025-05.
Reason for recall
Defective Container
Notes
Distribution: Nationwide within the United States
Lot/code information: Lot #: 15028, Exp 1/2023; 15379, Exp 3/2023.
Quantity: 5400 units
Status: Terminated
Products in this recall event:
- 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 (D-0258-2022)
- 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 70512-025-05. (D-0259-2022)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.