Why it was recalled
cGMP Deviation
Product description
Sunstar GUM Toothpaste 3 g tubes, Toothpaste made in Japan, packed in China, NDC 53050-0002-01
Lot numbers, UPCs & expiration codes
Lot #: 20180621 Exp. 2020-06-21, 20180827 Exp. 2020-08-27, 20190115 Exp. 2021-01-15
Where it was sold
Florida only
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-0997-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 28, 2020
- FDA report date
- Mar 18, 2020
- Quantity
- 260,000 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sunstar Guangzhou Ltd.
Original FDA data
Every field from FDA enforcement report D-0997-2020, exactly as published.
Show all FDA fields
- City
- Guangzhou
- Status
- Terminated
- Country
- China
- Event ID
- 85127
- Address
- Modern Industry Centre
- Address (line 2)
- Blk D F/5; 203 Conbo Avenue
- Code information
- Lot #: 20180621 Exp. 2020-06-21, 20180827 Exp. 2020-08-27, 20190115 Exp. 2021-01-15
- Report date
- Mar 18, 2020
- Product type
- Drugs
- Recall number
- D-0997-2020
- Classification
- Class II
- Recalling firm
- Sunstar Guangzhou Ltd.
- Product quantity
- 260,000 tubes
- Termination date
- Mar 29, 2021
- Reason for recall
- cGMP Deviation
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sunstar GUM Toothpaste 3 g tubes, Toothpaste made in Japan, packed in China, NDC 53050-0002-01
- Distribution pattern
- Florida only
- Recall initiation date
- Feb 28, 2020
- Initial firm notification
- Letter
- Center classification date
- Mar 9, 2020