The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-094-2013·Announced 2012-12-26

Watson Recalls Caziant Tablets Due to Out-of-Specification Impurities

Watson Laboratories is recalling Caziant tablets because out-of-specification results were obtained for a known impurity.

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 recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Watson Laboratories, Inc. is recalling Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen). The recall involves 63,627 cartons of the medication, which are distributed nationwide. The specific products affected are identified by the following lot codes and expiration dates: 432127A (Exp. 01/13), 478076A (Exp. 05/13), and 515539B (Exp. 09/13).

The recall was initiated because out-of-specification results were obtained for a known impurity. The FDA has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.

Consumers who have this product should contact their pharmacist or healthcare provider for guidance on how to dispose of the medication or obtain a replacement. The product is prescription-only, so patients should consult their prescriber regarding any changes to their medication regimen.

The recalled product

Product
Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1 mg/0.025 mg, 0.125 mg/0.025 mg, 0.15 mg/0.025 mg, 28-count tablets per dispenser (NDC 52544-959-28), packaged in 3-count Tablet Dispensers per carton (NDC 52544-959-31), Rx only Manufactured by…
Manufacturer
Watson Laboratories Inc
Category
Drug — Oral Contraceptive
Hazard
Affected units
63,627

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 (3)

  • 432127A Exp. 01/13
  • 478076A Exp. 05/13
  • 515539B Exp.09/13

Distribution

Distributed nationwide across the United States.

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