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Recall Observatory FDA recall evidence

Drug 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.

D-0259-2022

October 19, 2021

Class II

Product summary

Firm
Teligent Pharma, Inc.
Event
Event 88884
Status
Terminated
Classification
Class II
Quantity
5400 units
Official record key
drug-enforcement:D-0259-2022

Official wording

Reason: Defective Container

Code information: Lot #: 15028, Exp 1/2023; 15379, Exp 3/2023.

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Defective Container