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Class III · Low risk Terminated Initiated Feb 19, 2013 (14 years ago)

Novartis Lamisil AT Cream

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

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.

Cause type: Labeling / mix-up

Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.

What was recalled

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 with UPC code: 300673998308 and NDC code: 0067-3998-30; (d) 30 gm (1 oz), packaged with UPC code: 300673998339 and NDC code: 0067-3998-33.

Affected NDCs 0067-3998-12 0067-3998-30 0067-3998-33 0067-3998-42

Compare with the code on your package — it is the most precise check available.

Drug: Terbinafine

Recalling firm
Novartis Consumer Health
Origin
NE, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-573-2013 · FDA notice

Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other Terbinafine recalls

See all
Class II · Moderate risk

Terbinafine HCl active pharmaceutical ingredient packaged in…

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Terminated Cross-contamination Attix Pharmaceuticals D-921-2015
Class II · Moderate risk

Terbinafine Base active pharmaceutical ingredient packaged in…

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Terminated Cross-contamination Attix Pharmaceuticals D-920-2015
Class II · Moderate risk

Terbinafine active pharmaceutical ingredient packaged in varying…

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Terminated Cross-contamination Attix Pharmaceuticals D-919-2015
Class III · Low risk

Lamisil AT

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.

Terminated Labeling / mix-up Novartis Consumer Health NDC 0067-6171-85 D-420-2013
Class III · Low risk

Lamisil AT Cream

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.

Terminated Labeling / mix-up Novartis Consumer Health NDC 0067-6295-43 D-576-2013

Other recalls by Novartis Consumer Health

All 2013 recalls
Class III · Low risk

Loratadine

Failed Tablet/Capsule Specifications: The products are being recalled due to chipped and broken tablets.

Terminated Failed specification Novartis Consumer Health D-022-2014