The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-596-2013·Announced 2013-06-12

Voltaren 1% Gel Recalled for Illegible Lot and Expiration Dates

Physicians Total Care is recalling 76 tubes of Voltaren 1% Gel because the lot number and expiration date on the tubes may not be legible.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a labeling defect (illegible dates) rather than a safety hazard.

Plain-English summary

Physicians Total Care, Inc. is recalling 76 tubes of Voltaren 1% Gel, 100 gm tube, Rx only. The product is distributed nationwide. The recall was initiated because the lot number and expiration date on the tube may not be legible.

The affected product is manufactured by Novartis Consumer Health and distributed by Physicians Total Care. The recall covers specific lot numbers and expiration dates ranging from March 2013 to September 2014. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product is found, it should be removed from use and returned to the distributor or disposed of according to local regulations. No specific consumer action is required for those who have already used the product, as the hazard is related to labeling legibility rather than product safety.

The recalled product

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
Manufacturer
Physicians Total Care, Inc.
Category
Drug — Topical Analgesic
Hazard
Affected units
76

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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
  • Novartis #10088311. PTC #67J7
  • Novartis #10088311. PTC #68JC
  • Exp 05/31/2013
  • Novartis #10088899. PTC #68KA
  • Novartis #10088899. PTC #6B0I
  • Novartis #10088905. PTC #6AA4
  • Novartis #10088907. PTC #6D9R
  • Exp 07/31/2013
  • Novartis #10088924. PTC #6DBP
  • Novartis #10088925. PTC #6M81
  • Novartis #10088929. PTC #6ME2
  • Novartis #10088929. PTC #6F98
  • Exp 08/31/2013

Distribution

Distributed nationwide across the United States.

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