The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-1297-2014·Announced 2014-05-07

Caraco Recalls Children's Cetirizine Tablets Due to Impurity Failures

Caraco Pharmaceutical Laboratories is recalling 47,813 bottles of Children's Cetirizine Hydrochloride Chewable Tablets because they failed impurity testing for N-Oxide.

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 2/5 (Moderate).

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 recall is classified as FDA 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. A score of 2 is assigned to reflect the nature of the impurity failure while adhering to the Class III classification guidelines.

Plain-English summary

Caraco Pharmaceutical Laboratories, Ltd. is recalling 47,813 bottles of Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottles. The product is an over-the-counter medication manufactured by Sun Pharma in Gujarat, India, and distributed nationwide by Chain Drug Consortium in Boca Raton, FL. The recall involves specific lot codes: JKM2070A (Exp. 07/14), JKM2071A (Exp. 10/14), JKM2072A (Exp. 01/15), JKM2072B (Exp. 01/15), and JKM6400A (Exp. 04/15).

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

Consumers who have these specific bottles should stop using the product and contact their pharmacist or the recalling firm for instructions on how to return the medication or obtain a refund.

The recalled product

Product
Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle, OTC, Manufactured by Sun Pharma, Gujarat, India, Distributed Chain Drug Consortium, Boca Raton, FL, NDC 47335-344-83
Manufacturer
Caraco Pharmaceutical Laboratories, Ltd.
Category
Drug — Over-the-Counter
Hazard
Affected units
47,813

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 (5)

  • JKM2070A Exp. 07/14
  • JKM2071A Exp.10/14
  • JKM2072A Exp. 01/15
  • JKM2072B Exp. 01/15
  • JKM6400A 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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