The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1296-2014·Announced 2014-05-07

Caraco Recalls Cetirizine Hydrochloride Chewable Tablets Due to Impurities

Caraco Pharmaceutical Laboratories is recalling specific lots of Cetirizine Hydrochloride Chewable Tablets because they failed impurity testing.

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 as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor specification issues.

Plain-English summary

Caraco Pharmaceutical Laboratories, Ltd. is recalling 128,363 bottles of Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count. The product is an over-the-counter medication manufactured by Sun Pharma in Gujarat, India, and distributed nationwide. The recall is limited to specific lots with expiration dates ranging from July 2014 to April 2015.

The recall was initiated because the product failed impurities and degradation specifications. Specifically, testing revealed out-of-specification results for N-Oxide impurities. The U.S. Food and Drug Administration has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.

Consumers who have these specific bottles should stop using the product and contact Caraco Pharmaceutical Laboratories or their healthcare provider for further instructions. The affected NDC is 47335-343-83.

The recalled product

Product
Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83
Manufacturer
Caraco Pharmaceutical Laboratories, Ltd.
Category
Drug — Over-the-Counter
Hazard
Affected units
128,363

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 (4)

  • JKM2067A Exp. 07/14
  • JKM2068A Exp.10/14
  • JKM2069A Exp. 01/15
  • JKM6399A Exp. 04/15

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Caraco Pharmaceutical Laboratories, Ltd. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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