Why it was recalled
Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.
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.
Lot numbers, UPCs & expiration codes
Lot #: JKR5135A, Exp 11/17
Where it was sold
Nationwide in the USA and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0857-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 18, 2017
- FDA report date
- May 31, 2017
- Quantity
- 13,200 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
Original FDA data
Every field from FDA enforcement report D-0857-2017, exactly as published.
Show all FDA fields
- City
- Cranbury
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 77103
- Address
- 270 Prospect Plains Rd
- Code information
- Lot #: JKR5135A, Exp 11/17
- Postal code
- 08512-3605
- Report date
- May 31, 2017
- Product type
- Drugs
- Recall number
- D-0857-2017
- Classification
- Class III
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
- Product quantity
- 13,200 bottles
- Termination date
- May 18, 2018
- Reason for recall
- Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Apr 18, 2017
- Initial firm notification
- Letter
- Center classification date
- May 23, 2017