Why it was recalled
Incorrect/Undeclared Excipients: ZEE Medical is recalling ZEE Aspirin due to the incorrect listing of inactive ingredients on the product label.
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
Lot numbers, UPCs & expiration codes
Lot No. AK5425, AK5172, AK5548, AK6047, AK6114, AK5865, AK5963, AK6175, AK6346, AK6438, AK7062
Where it was sold
Nationwide in US
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0041-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 7, 2014
- FDA report date
- Oct 29, 2014
- Quantity
- 43,752 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zee Medical Products Inc
Original FDA data
Every field from FDA enforcement report D-0041-2015, exactly as published.
Show all FDA fields
- City
- Irvine
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 69538
- Address
- 22 Corporate Park
- Code information
- Lot No. AK5425, AK5172, AK5548, AK6047, AK6114, AK5865, AK5963, AK6175, AK6346, AK6438, AK7062
- Postal code
- 92606-3112
- Report date
- Oct 29, 2014
- Product type
- Drugs
- Recall number
- D-0041-2015
- Classification
- Class II
- Recalling firm
- Zee Medical Products Inc
- Product quantity
- 43,752 boxes
- Termination date
- Apr 24, 2015
- Reason for recall
- Incorrect/Undeclared Excipients: ZEE Medical is recalling ZEE Aspirin due to the incorrect listing of inactive ingredients on the product label.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in US
- Recall initiation date
- Oct 7, 2014
- Initial firm notification
- Letter
- Center classification date
- Oct 22, 2014