The Recall Desk
ModerateFDA (Drugs)·D-1436-2012·Announced 2012-08-08

Watson Recalls Caziant Tablets Due to High Impurity Levels

Watson Laboratories is recalling Caziant tablets because high levels of impurities were detected. Consumers should stop using the product and contact their healthcare provider.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The FDA classified this as a Class III recall, which is typically a low-risk issue. The hazard involves impurities, but the agency's classification suggests it is unlikely to cause serious harm, fitting the Moderate category for minor quality deviations.

Plain-English summary

Watson Laboratories, Inc. is recalling 18,938 cartons of Caziant (desogestrel and ethinyl estradiol) Tablets, USP. The recall involves specific lots (412572A and 412572B) with an expiration date of 11/12. The product was distributed nationwide.

The recall was initiated because high out-of-specification results were obtained for both known and unknown impurities. This indicates that the tablets contained degradation products or impurities at levels exceeding the acceptable standards.

Consumers who have this product should stop using it and contact their healthcare provider for further instructions. The FDA has classified this recall as Class III, which means it is not likely to cause adverse health consequences.

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: Wa
Affected units
18,938

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)

  • Lot #s: 412572A
  • 412572B
  • Exp 11/12

Distribution

Distributed nationwide across the United States.