Why it was recalled
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
Product description
Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle, OTC, Manufactured by Sun Pharma, Gujarat, India, Distributed Chain Drug Consortium, Boca Raton, FL, NDC 47335-344-83
Lot numbers, UPCs & expiration codes
JKM2070A Exp. 07/14, JKM2071A Exp.10/14, JKM2072A Exp. 01/15, JKM2072B Exp. 01/15, JKM6400A Exp. 04/15
Where it was sold
Nationwide
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-1297-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 9, 2014
- FDA report date
- May 7, 2014
- Quantity
- 47,813 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Caraco Pharmaceutical Laboratories, Ltd.
Original FDA data
Every field from FDA enforcement report D-1297-2014, exactly as published.
Show all FDA fields
- City
- Detroit
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 67971
- Address
- 1150 Elijah McCoy Dr
- Code information
- JKM2070A Exp. 07/14, JKM2071A Exp.10/14, JKM2072A Exp. 01/15, JKM2072B Exp. 01/15, JKM6400A Exp. 04/15
- Postal code
- 48202-3344
- Report date
- May 7, 2014
- Product type
- Drugs
- Recall number
- D-1297-2014
- Classification
- Class III
- Recalling firm
- Caraco Pharmaceutical Laboratories, Ltd.
- Product quantity
- 47,813 bottles
- Termination date
- Oct 7, 2014
- Reason for recall
- Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle, OTC, Manufactured by Sun Pharma, Gujarat, India, Distributed Chain Drug Consortium, Boca Raton, FL, NDC 47335-344-83
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 9, 2014
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- May 1, 2014