Recalls / Class III

Class IIID-596-2013

Product

Voltaren 1% Gel, 100 gm tube, Rx only, Dist By: Physicians Total Care, Tulsa OK 74146, Mfg By: Novartis Consumer Health, Parsippany, NJ 07054, NDC 54868-5965-00

Affected lot / code info

PTC Lot #; Exp Date; Distributor Novartis Lot #. PTC #651L; Exp 03/31/2013; Novartis #10085272. PTC #G8OO; Exp 04/30/2013; Novartis #10088292. PTC #67GO; Exp 04/30/2013; Novartis #10088311. PTC #67J7; Exp 04/30/2013; Novartis #10088311. PTC #68JC; Exp 05/31/2013; Novartis #10088899. PTC #68KA; Exp 05/31/2013; Novartis #10088899. PTC #6B0I; Exp 05/31/2013; Novartis #10088905. PTC #6AA4; Exp 05/31/2013; Novartis #10088907. PTC #6D9R; Exp 07/31/2013; Novartis #10088924. PTC #6DBP; Exp 07/31/2013; Novartis #10088925. PTC #6M81; Exp 07/31/2013; Novartis #10088929. PTC #6ME2; Exp 07/31/2013; Novartis #10088929. PTC #6F98; Exp 08/31/2013; Novartis #10094389. PTC #6QFU; Exp 09/30/2013; Novartis #10094396. PTC #6I2S; Exp 10/31/2013; Novartis #10098702. PTC #6KJG; Exp 12/31/2013; Novartis #10102313. PTC #6KC1; Exp 12/31/2013; Novartis #10102314. PTC #6SQ7; Exp 02/28/2014; Novartis #10104248. PTC #6Q3B; Exp 03/31/2014; Novartis #10107749. PTC #6NRO; Exp 03/31/2014; Novartis #10107750. PTC #6OVH; Exp 03/31/2014; Novartis #10107750. PTC #6QTV; Exp 04/30/2014; Novartis #10110442. PTC #6REN; Exp 04/30/2014; Novartis #10110442. PTC #6ROG; Exp 04/30/2014; Novartis #10110442. PTC #6VGM; Exp 05/31/2014; Novartis #10113476. PTC #6VOR; Exp 05/31/2014; Novartis #10113476. PTC #6VQ2; Exp 05/31/2014; Novartis #10113476. PTC #6VWW; Exp 05/31/2014; Novartis #10113476. PTC #6SQ6; Exp 05/31/2014; Novartis #10113478. PTC #6XO2; Exp 05/31/2014; Novartis #10113481. PTC #6Y4L; Exp 05/31/2014; Novartis #10113481. PTC #6YTH; Exp 05/31/2014; Novartis #10113481. PTC #6V3L; Exp 06/30/2014; Novartis #10115860. PTC #6X79; Exp 09/30/2014; Novartis #10119418. PTC #6WQ4; Exp 09/30/2014; Novartis #10120557.

Why it was recalled

Labeling: Incorrect or Missing Lot and/or Expiration Date; This recall is being initiated because the lot number and expiration date on the tube may not be legible.

Recalling firm

Firm

Physicians Total Care, Inc.

Notification channel

FAX

Type

Voluntary: Firm initiated

Address

12515 E 55th St Ste 100, N/A, Tulsa, Oklahoma 74146-6234

Distribution

Quantity

76 Tubes

Distribution pattern

Nationwide

Timeline

Recall initiated

2013-03-02

FDA classified

2013-06-06

Posted by FDA

2013-06-12

Terminated

2013-07-01

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-596-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.