FDAFDA · Food and drugs·Recall number D-0857-2017
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.
Published May 31, 2017 · Recall initiated: April 18, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Distributor
- Nationwide in the USA and Puerto Rico
- Lot
- Lot #: JKR5135A, Exp 11/17
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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