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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) bottle, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-002-05.

D-0679-2022

March 15, 2022

Class II

Product summary

Firm
Teligent Pharma, Inc.
Event
Event 89798
Status
Terminated
Classification
Class II
Quantity
16,643 bottles
Official record key
drug-enforcement:D-0679-2022

Official wording

Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Code information: Batch: 15066, 15389 Exp. 3/31/2023; 15437, Exp. 12/31/2023; 16823, Exp. 4/30/2024; 16825, 16826, Exp. 4/30/2024

Distribution pattern: Nationwide in the USA and Puerto Rico

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP deviations