FDA-Drug2017-05-31Class III
Children's Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30-count bottle, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol - 389 350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 47335-343-83.
Sun Pharmaceutical Industries, Inc.
Hazard
Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.
Sold states
Nationwide in the USA and Puerto Rico
Affected count
13,200 bottles
Manufactured in
270 Prospect Plains Rd, Cranbury, NJ, United States
Products
Children's Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30-count bottle, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol - 389 350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 47335-343-83.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0857-2017Don't want to check this manually?
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