Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83

FDA recall notice · announced May 7, 2014 · Caraco Pharmaceutical Laboratories

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83

Reason for recall

Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide

Notes

Distribution: Nationwide
Lot/code information: JKM2067A Exp. 07/14, JKM2068A Exp.10/14, JKM2069A Exp. 01/15, JKM6399A Exp. 04/15
Quantity: 128,363 bottles
Status: Terminated
Products in this recall event:
- 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 (D-1297-2014)
- Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83 (D-1296-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.