Recalls / Class III
Class IIID-0857-2017
Product
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.
- Brand name
- Cetirizine Hydrochloride
- Generic name
- Cetirizine Hydrochloride
- Active ingredient
- Cetirizine Hydrochloride
- Route
- Oral
- NDCs
- 47335-343, 47335-344
- FDA application
- ANDA090142
- Affected lot / code info
- Lot #: JKR5135A, Exp 11/17
Why it was recalled
Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.
Recalling firm
- Firm
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 270 Prospect Plains Rd, Cranbury, New Jersey 08512-3605
Distribution
- Quantity
- 13,200 bottles
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2017-04-18
- FDA classified
- 2017-05-23
- Posted by FDA
- 2017-05-31
- Terminated
- 2018-05-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0857-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.