Drug recall: Novartis Lamisil AT Cream, Terbinafine Hydrochloride Cream 1% Antifungal, Novartis Consumer Health, Inc., Parsippany…
Class III FDA enforcement event 64372. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
Class III, in the words of FDA
a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences
Novartis Consumer Health started this drug recall on 19 Feb 2013. The firm address in the FDA record is in Lincoln, NE. FDA put the recall in Class III. FDA event 64372 has 5 product records. The first FDA enforcement report date is 12 Jun 2013. The record gives the status Terminated, with the termination date 26 Nov 2014.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide and Puerto Rico, and Panama. Military distribution made.
Recalling firm
Novartis Consumer Health, Lincoln, NE.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
5 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-573-2013 | Novartis Lamisil AT Cream, Terbinafine Hydrochloride Cream 1% Antifungal, Novartis Consumer Health, Inc., Parsippany, NJ. (a)12 gm (.42 oz), packaged with UPC code 300673998421 and NDC code: 0067-3998-42; (b) 12 gm (.42 oz), packaged with UPC code: 300673998124 and NDC code: 0067-3998-12; (c) 30 gm (1 oz), packaged… | 818,064 (12-gm) tubes and 836,376 (30-gm) tubes | Class III | Terminated | 12 Jun 2013 |
| D-574-2013 | Target Up & Up, athlete's foot cream, full prescription strength, terbinafine hydrochloride 1% antifungal, 30 g (1 oz), compare to active ingredient in Lamisil, NDC 0067-6382-30 & UPC code: 300676382302 (Novartis) Target NDC 1167-3401-04, Distributed by Target Corp., Minneapolis, MN. | 99,660 tubes | Class III | Terminated | 12 Jun 2013 |
| D-575-2013 | Novartis Lamisil AT Cream for Jock Itch (terbinafine hydrochloride 1% antifungal), a) 12 g (.42 oz) Tube, NDC 0067-3999-12, Novartis Consumer Health, Inc., Parsitan, NJ. UPC code: 300673999121, (Vertical Pack) and b) packaged in a horizontal package12 gm (.42 oz) Tube, NDC 0067-3999-42, Novartis Consumer Health,… | 219,600 tubes | Class III | Terminated | 12 Jun 2013 |
| D-576-2013 | Lamisil AT Cream (terbinafine hydrochloride 1% antifungal), 12 gm ( .42 oz) Tubes and 30 gm (1 oz) Tubes packaged in one box, Novartis Consumer Health, Inc., Parsitan, NJ. UPC code: 300676249438. (Club Pack), NDC 0067-6295-43 | 41,400 Boxes | Class III | Terminated | 12 Jun 2013 |
| D-577-2013 | Voltaren Gel (diclofenac sodium topical gel) 1%, for topical use only, RX only, a) Packaged in 20 gm tubes, NDC 63481-684-83 (physician sample product) and b) 100 gm tubes, NDC 63481-684-47 (the 100 g tubes are also packaged 3/100-g tubes/packs (UPC code: 363481684030 NDC code: 6348168403) and 5/100-g tubes/packs… | a) 1,043,926 (20-gm) tubes and b) 3,385,481 (100-gm) tubes | Class III | Terminated | 12 Jun 2013 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class III: The lowest of the three FDA recall classes.
The event in context
- Drug events that started in 2013
- 370
- Share of these events in Class III
- 26%
- Product records in this event
- 5Median of the firm: 5
- Events of the firm on the register
- 11
Other events of the firm
Official channels
- FDA enforcement report D-573-2013The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 64372. https://recallregister.com/fda/iii/64372/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide and Puerto Rico, and Panama. Military distribution made.
- What quantity of product is in FDA event 64372?
- The event has 5 product records. The first record gives this quantity:
818,064 (12-gm) tubes and 836,376 (30-gm) tubes
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2013 have the same class?
- 26% of the 370 drug events that started in 2013 are in Class III.