Why it was recalled
Marketed Without an Approved NDA/ANDA
Product description
No. 1 Faiza Beauty Cream Manufactured by: Poonia Brothers (Pak), Gujranwala, Distributed by Shata Traders Inc., 4, 19th Street, Brooklyn, NY 11232. UPC 5842109854239
Lot numbers, UPCs & expiration codes
Batch # 16L63 Lot # 223190
Where it was sold
NY
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-0084-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 22, 2017
- FDA report date
- Nov 29, 2017
- Quantity
- 96 foil packages
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Shata Trading, Inc.
Original FDA data
Every field from FDA enforcement report D-0084-2018, exactly as published.
Show all FDA fields
- City
- Brooklyn
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 78257
- Address
- 4 19th St
- Code information
- Batch # 16L63 Lot # 223190
- Postal code
- 11232-1012
- Report date
- Nov 29, 2017
- Product type
- Drugs
- Recall number
- D-0084-2018
- Classification
- Class II
- Recalling firm
- Shata Trading, Inc.
- Product quantity
- 96 foil packages
- Termination date
- Jul 9, 2020
- Reason for recall
- Marketed Without an Approved NDA/ANDA
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- No. 1 Faiza Beauty Cream Manufactured by: Poonia Brothers (Pak), Gujranwala, Distributed by Shata Traders Inc., 4, 19th Street, Brooklyn, NY 11232. UPC 5842109854239
- Distribution pattern
- NY
- Recall initiation date
- Aug 22, 2017
- Initial firm notification
- Letter
- Center classification date
- Nov 19, 2017