URGENT!!! RECALL EXPANDED TO CONSUMER LEVEL! URGENT!!!
LEVEL OF NOTIFICATION: Consumer
Description Lot # Exp Date NDC
MIBELAS 24 FE TB 1/.02MG 3X28 L600518 05/31/18 68180091113
MIBELAS 24 FE TB 1/.02MG 1X28 L600518 05/31/18 68180091111
Lupin is voluntarily recalling the above items/lot due to a packaging error, where one blister was rotated 180 degrees within the wallet, reversing the weekly tablet orientation and making the lot number and expiry date no longer visible. This recall is to the Consumer level. Affected product started shipping March 15, 2017.
Consumers affected by this recall should contact GENCO Pharmaceutical Services via telephone at 1-855-633-1428, to obtain a returns packet and initiate the return of the affected product
NOTE: Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either by phone, online, by regular mail or by fax.
• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
GENCO: GENCO CUSTOMER SERVICE 877-319-8966