D-0041-2015 Class II Terminated
FDA drug recall D-0041-2015 was initiated by Zee Medical Products Inc on October 7, 2014 and is designated Class II. Reason for recall: Incorrect/Undeclared Excipients: ZEE Medical is recalling ZEE Aspirin due to the incorrect listing of inactive ingredients on the product label. The recall status is terminated (terminated April 24, 2015). Affected quantity: 43,752 boxes.
Recall Details
- Product Type
- Drugs
- Report Date
- October 29, 2014
- Initiation Date
- October 7, 2014
- Termination Date
- April 24, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 43,752 boxes
Product Description
ZEE Aspirin 325mg - 24 tablets in single dose packets, OTC, Manufactured for ZEE Medical Inc., Irvine,CA 92606 by ULTRA Tab Laboratories, Inc. Highland, NY 12528
Reason for Recall
Incorrect/Undeclared Excipients: ZEE Medical is recalling ZEE Aspirin due to the incorrect listing of inactive ingredients on the product label.
Distribution Pattern
Nationwide in US
Code Information
Lot No. AK5425, AK5172, AK5548, AK6047, AK6114, AK5865, AK5963, AK6175, AK6346, AK6438, AK7062