Drug product
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
D-0041-2015
Product summary
- Event
- Event 69538
- Status
- Terminated
- Classification
- Class II
- Quantity
- 43,752 boxes
- Official record key
drug-enforcement:D-0041-2015
Official wording
Reason: Incorrect/Undeclared Excipients: ZEE Medical is recalling ZEE Aspirin due to the incorrect listing of inactive ingredients on the product label.
Code information: Lot No. AK5425, AK5172, AK5548, AK6047, AK6114, AK5865, AK5963, AK6175, AK6346, AK6438, AK7062
Distribution pattern: Nationwide in US
Derived failure modes
-
Unknown
Incorrect/Undeclared Excipients: ZEE Medical is recalling ZEE Aspirin due to the incorrect listing of inactive ingredients on the product label.