• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of May 8, 2013

  • Print
  • Share
  • E-mail
-

Product Detail

Product Description Cherry Cepacol Sore Throat Lozenges, Benzocaine 15 mg | Menthol 3.6 mg, a)16-count, NDC 63824-711-16 b) Institutional Size, 576-count, NDC 63824-711-98, OTC, Dist. by: Reckitt Benckiser, Parsippany, NJ 07054
Recall Number D-310-2013
Classification Class III
Code Info 16 count: AG156 Exp 11/13, AG257 Exp 12/13, AH388 02/14, AJ167 03/14, AL367 Exp 05/14, AL555 & AL568 Exp 06/14, AM141 Exp 07/14. 576 Count: AK505 Exp 04/14, AK570 Exp 05/14, AH368 & AH398 Exp 02/14, AJ000 Exp 03/14, AG596 Exp 12/13,
Product Distributed Qty 27,718 cases 16 count and 7,551 cases 576 count
Reason For Recall Subpotent Drug: Product did not conform to the 18-month stability test specification for active Free Benzocaine.

Event Detail

Event Id 64652
Product Type Drugs
Status Ongoing
Recalling Firm Reckitt Benckiser Inc
City Parsippany
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-18
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide
-
-