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

Enforcement Report - Week of February 19, 2014

  • Print
  • Share
  • E-mail
-

Product Detail

Product Description OroCAM is supplied in three glass vial sizes containing 6 mL, 11 mL and 33 mL of meloxicam. Each vial has a different metered dose pump delivering a dose of 0.25 mg, 0.50 mg, or 1.075 mg, per spray, respectively. Manufactured for Abbott Laboratories; North Chicago, IL 60064 USA; Product of Spain
Recall Number V-053-2014
Classification Class II
Code Info *** US PRODUCTS *** 1) 6 mL Vials. List Number 04943-04-01. Lot Codes and Expiration Dates: EMFG, 11/2014; FBDN, 02/2015; FEBU-3, 05/2015, FEBU-1, 05/2015. 2) 11 mL Vials. List Number 04943-04-02. Lot Codes and Expiration Dates: EMFF, 11/2014; FEBU-2, 05/2015. 3) 13 mL Vials. List Number 04943-04-03. Lot Codes and Expiration Dates: EMFG-1, 11/2014; EMGL, 11/2014; EMGM, 11/2014, EMGN, 11/2014. *** FOREIGN PRODUCTS *** 4) 6 mL Vials. List Number 04943-90-01. Lot Codes and Expiration Dates: EDEG-2, 05-2014; EKFE, 9-2014. 5) 6 mL Vials. List Number 04943-27-01. Lot Codes and Expiration Dates: EDEG, 05-2014. 6) 6 mL Vials. List Number 04943-03-01. Lot Codes and Expiration Dates: 33008XN, 10-2015.; 33004XN, 10-2015. 7) 11 mL vials. List Number 04943-90-02. Lot Codes and Expiration Dates: EDEG-3, 05 -2014; EFKE-1, 09-2014. 8) 11 mL Vials. List Number 04943-27-02. Lot Codes and Expiration Dates: EDGE-1, 05-2014. 9) 33 mL Vials. List Number 04943-27-03. Lot Codes and Expiration Dates: EDEH, 05-2014; EDEF, 04-2014; EHGM, 08-2014. 10) 33 mL Vials. List Number 04943-90-03. Lot Codes and Expiration Dates: EFFW, 06-2014; EHEK, 09-2014.
Product Distributed Qty *** US PRODUCTS *** 6 mL Vials: 14,527 vials. 11 mL Vials: 14,104 vials. 33 mL Vials: 13,306 vials.
Reason For Recall Some particles were observed in a limited number of OroCAM units. The particles if present could clog the pump mechanism and could also potentially result in under-administration.

Event Detail

Event Id 67113
Product Type Veterinary
Status Ongoing
Recalling Firm Abbott Laboratories
City Abbott Park
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-12-11
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US: Nationwide (AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY,LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV); FOREIGN: Austria, Belgium, Canada, Finland, France, Germany, Ireland, Netherlands, Spain, Switzerland, United Kingdom
-
-