FDA Recall Terminated Historical recordClass 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.
- Reason
- Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.
- Published
- May 31, 2017
- Distribution
- Nationwide
