Class III · Low risk
Gabapentin Oral Solution
CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.
No. 1 Faiza Beauty Cream Manufactured by: Poonia Brothers
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Marketed Without an Approved NDA/ANDA
Cause type: Unapproved drug
The product was marketed without an approved NDA/ANDA, or does not meet the OTC monograph it claims to follow. Nothing about the product - dose, purity, safety - has been reviewed by FDA, so the claims on the box are unverified. All unapproved drug recalls.
What was recalled
No. 1 Faiza Beauty Cream Manufactured by: Poonia Brothers (Pak), Gujranwala, Distributed by Shata Traders Inc., 4, 19th Street, Brooklyn, NY 11232. UPC 5842109854239
- Recalling firm
- Shata Trading, Inc.
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0084-2018 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other unapproved drug recalls from 2017
All unapproved drug recalls
Class III · Low risk
Meclizine hydrochloride tablets USP
Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.
Class II · Moderate risk
No.1 Faiza Beauty Cream Manufactured by: Poonia Brothers
Marketed Without an Approved NDA/ANDA
Class I · High risk
D-ZINE Rapid Size and Strength capsules
Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine.
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