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.
Product description
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
Lot numbers, UPCs & expiration codes
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.
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-596-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 2, 2013
- FDA report date
- Jun 12, 2013
- Quantity
- 76 Tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Physicians Total Care, Inc.
Original FDA data
Every field from FDA enforcement report D-596-2013, exactly as published.
Show all FDA fields
- City
- Tulsa
- State
- OK
- Status
- Terminated
- Country
- United States
- Event ID
- 65295
- Address
- 12515 E 55th St Ste 100
- Code information
- 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.
- Postal code
- 74146-6234
- Report date
- Jun 12, 2013
- Product type
- Drugs
- Recall number
- D-596-2013
- Classification
- Class III
- Recalling firm
- Physicians Total Care, Inc.
- Product quantity
- 76 Tubes
- Termination date
- Jul 1, 2013
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 2, 2013
- Initial firm notification
- FAX
- Center classification date
- Jun 6, 2013