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.
Reported: May 31, 2017 Initiated: April 18, 2017 #D-0857-2017
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.
Details
- Recalling Firm
- Sun Pharmaceutical Industries, Inc.
- Units Affected
- 13,200 bottles
- Distribution
- Nationwide in the USA and Puerto Rico
- Location
- Cranbury, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Sun Pharmaceutical Industries, Inc.. Units affected: 13,200 bottles.
Why was this product recalled? ▼
Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 31, 2017. Severity: Low. Recall number: D-0857-2017.
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