CLASS II Drug recall · Reported 14 Feb 2018 · FDA Enforcement Report
TP Drug Laboratories Vitamin C ampules recalled by Flawless Beauty
Flawless Beauty is recalling TP Drug Laboratories Vitamin C ampules, distributed nationwide in the US. The recall was initiated on 19 Jan 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0331-2018
- FDA event ID
- 78991
- Recalling firm
- Flawless Beauty, Asbury Park, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Jan 2018
- FDA classified
- 5 Feb 2018
- Reported
- 14 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Labeling Errors
- Drug class
- Vitamins & OTC Supplements
Timeline
| 19 Jan 2018 | Recall initiated by company | |
| 5 Feb 2018 | Classified by FDA | +17 days |
| 14 Feb 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
TP Drug Laboratories Vitamin C ampules
Where it was distributed
Product was distributed U.S.A. nationwide.
Questions about this recall
Is TP Drug Laboratories Vitamin C ampules recalled?
Yes. Flawless Beauty recalled TP Drug Laboratories Vitamin C ampules on 19 Jan 2018. The recall is Class II and its status is Terminated. Recall number D-0331-2018.
Why was it 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.
Which lots are affected?
all lots
Where was it sold?
Product was distributed U.S.A. nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Flawless Beauty
All 18| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sterilized water for injections BP, mL plastic ampules recalled | Flawless Beauty | Labeling Errors | Nationwide |
| Drug | CLASS II | Saluta Glutathione Whitening kits recalled by Flawless Beauty | Flawless Beauty | Labeling Errors | Nationwide |
| Drug | CLASS II | TAD Glutathione Whitening Kits lyophilized powder recalled | Flawless Beauty | Labeling Errors | Nationwide |
| Drug | CLASS II | Laroscorbine Platinum Vitamin C 1 gm Collagen 35 gm, Roche recalled | Flawless Beauty | Labeling Errors | Nationwide |
| Drug | CLASS II | Reiki Glutathione Whitening kits recalled by Flawless Beauty | Flawless Beauty | Labeling Errors | Nationwide |