D-0857-2017 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 31, 2017
- Initiation Date
- April 18, 2017
- Termination Date
- May 18, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,200 bottles
Product Description
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 for Recall
Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.
Distribution Pattern
Nationwide in the USA and Puerto Rico
Code Information
Lot #: JKR5135A, Exp 11/17