Vitamin C (ascorbic acid) Injection, USP, 500 mg per 2 mL, 50 x 2 mL ampoules per box, Manufactur...
FDA Drug Recall #D-1320-2014 — Class II — April 29, 2014
Recall Summary
| Recall Number | D-1320-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 29, 2014 |
| Status | Completed |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Flawless Beauty LLC |
| Location | Asbury Park, NJ |
| Product Type | Drugs |
| Quantity | unknown |
Product Description
Vitamin C (ascorbic acid) Injection, USP, 500 mg per 2 mL, 50 x 2 mL ampoules per box, Manufactured by: TP Drug Laboratories (1969) Co., Ltd., 98 Soi Sukhumvlt 62, Yak 1, Bangchak, Prakanong, Bangkok 10260, Thailand, Reg. No. 1 A 1557/30; UPC 8 853533 000533
Reason for Recall
Marketed Without An Approved NDA/ANDA: Parenteral product is sold over the counter whose labeling indicates it is to be used for the treatment of disease.
Distribution Pattern
Nationwide
Lot / Code Information
Lot #: 556273, Exp 9/25/16; 556219, Exp 8/2/16, or any other lot distributed by Flawless Beauty.
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 using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced 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.