Multi-event April 2014 FDA Recall Cetirizine Hydrochloride by Caraco Pharmaceutical Laboratories, Ltd.
This Multi-event Class III drug recall was voluntarily initiated by Caraco Pharmaceutical Laboratories, Ltd. on April 9, 2014 for the product Cetirizine Hydrochloride. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1296-2014
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
04-09-2014
05-07-2014
128,363 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Caraco Pharmaceutical Laboratories, Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
10-07-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83
Batch or Lot Expiration Information
Lot# JKM2067A Exp. 07/14, JKM2068A Exp.10/14, JKM2069A Exp. 01/15, JKM6399A Exp. 04/15
Affected Packages Involved in this Recall
Recall Number: D-1297-2014
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
04-09-2014
05-07-2014
47,813 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Caraco Pharmaceutical Laboratories, Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
10-07-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# JKM2070A Exp. 07/14, JKM2071A Exp.10/14, JKM2072A Exp. 01/15, JKM2072B Exp. 01/15, JKM6400A Exp. 04/15
