Class III
Terminated
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.
- Recall Initiated
- April 18, 2017
- Posted
- May 31, 2017
- Recall Number
- D-0857-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 13,200 bottles
- Firm Location
- Cranbury, NJ, United States
Reason for Recall
Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.
Distribution
Nationwide in the USA and Puerto Rico
Lot / Code Info
Lot #: JKR5135A, Exp 11/17
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