Reported May 31, 2017 · Terminated
Children's Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30-count bottle, Manufactured by: Sun Pharmaceutical Ind.…
Sun Pharmaceutical Industries, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sun Pharmaceutical Industries, Inc. · 270 Prospect Plains Rd · Cranbury, NJ · 08512-3605
Is this the product you have?
- Children's Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30-count bottle
- Manufactured bySun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol - 389 350, Gujarat, India
- Distributed bySun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 47335-343-83
- Lot codes and dates
Lot #: JKR5135AExp 11/17
- Amount recalled
- 13,200 bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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