Why it was recalled
Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.
Product description
Sterilized water for injections BP, 50 x 5 mL plastic ampules, Manufactured in India
Lot numbers, UPCs & expiration codes
all lots
Where it was sold
Product was distributed U.S.A. nationwide.
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-0332-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 19, 2018
- FDA report date
- Feb 14, 2018
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Flawless Beauty LLC
Original FDA data
Every field from FDA enforcement report D-0332-2018, exactly as published.
Show all FDA fields
- City
- Asbury Park
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 78991
- Address
- 1215 Main St
- Code information
- all lots
- Postal code
- 07712-5940
- Report date
- Feb 14, 2018
- Product type
- Drugs
- Recall number
- D-0332-2018
- Classification
- Class II
- Recalling firm
- Flawless Beauty LLC
- Termination date
- Sep 13, 2018
- Reason for recall
- Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sterilized water for injections BP, 50 x 5 mL plastic ampules, Manufactured in India
- Distribution pattern
- Product was distributed U.S.A. nationwide.
- Recall initiation date
- Jan 19, 2018
- Initial firm notification
- Press Release
- Center classification date
- Feb 5, 2018