September 2012 FDA Recall Cetirizine Hydrochloride by Sandoz Incorporated (D-008-2013 - Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2))

This Class III drug recall was voluntarily initiated by Sandoz Incorporated on September 20, 2012 for the product Cetirizine Hydrochloride. The FDA reported the reason for recall as impurity/degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2). The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-008-2013

Reason for Recall
Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
Initiated
09-20-2012
Reported
10-24-2012
Quantity
67,937 x 30 tablet cartons; 24,640 x 5 tablet cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63224
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sandoz Incorporated
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-14-2013
Product Description About Product Description
Full technical description of the product.
Children's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ NDC 0781-5283-64 --- ALSO sold under Major brand All Day Allergy Children's Cetirizine HCl 5 mg, 5 count blister pack, Major Pharmaceuticals, Livonia, MI NDC 0904-5878-33

Batch or Lot Expiration Information

Lot# NDC 0781-5283-64 lots: BT2862, BT7986, BT7994, BW0652, CC1961, and CA3437; NDC 0904-5878-33 lot BW0665.

Affected Packages Involved in this Recall

0781-5283-06 Cetirizine Hydrochloride
0781-5283-64 Cetirizine Hydrochloride