Laroscorbine Platinum Vitamin C 1 gm Collagen 0.35 gm, Roche
FDA Drug Recall #D-0327-2018 — Class II — January 19, 2018
Recall Summary
| Recall Number | D-0327-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 19, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Flawless Beauty LLC |
| Location | Asbury Park, NJ |
| Product Type | Drugs |
| Quantity | N/A |
Product Description
Laroscorbine Platinum Vitamin C 1 gm Collagen 0.35 gm, Roche
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.
Distribution Pattern
Product was distributed U.S.A. nationwide.
Lot / Code Information
all lots
Other Recalls from Flawless Beauty LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0333-2018 | Class II | Ling Zhi capsules | Jan 19, 2018 |
| D-0331-2018 | Class II | TP Drug Laboratories Vitamin C ampules | Jan 19, 2018 |
| D-0325-2018 | Class II | Relumins Vitamin C Solvent ampules | Jan 19, 2018 |
| D-0332-2018 | Class II | Sterilized water for injections BP, 50 x 5 mL p... | Jan 19, 2018 |
| D-0328-2018 | Class II | Tationil Glutathione, 600 mg/ 4 mL, polvere e s... | Jan 19, 2018 |
Frequently Asked Questions
Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.