Why it was recalled
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.
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
Lot numbers, UPCs & expiration codes
Lot #: 556273, Exp 9/25/16; 556219, Exp 8/2/16, or any other lot distributed by Flawless Beauty.
Where it was sold
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-1320-2014
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Apr 29, 2014
- FDA report date
- May 21, 2014
- Quantity
- unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Flawless Beauty LLC
Original FDA data
Every field from FDA enforcement report D-1320-2014, exactly as published.
Show all FDA fields
- City
- Asbury Park
- State
- NJ
- Status
- Completed
- Country
- United States
- Event ID
- 68158
- Address
- 1215 Main St
- Code information
- Lot #: 556273, Exp 9/25/16; 556219, Exp 8/2/16, or any other lot distributed by Flawless Beauty.
- Postal code
- 07712-5940
- Report date
- May 21, 2014
- Product type
- Drugs
- Recall number
- D-1320-2014
- Classification
- Class II
- Recalling firm
- Flawless Beauty LLC
- Product quantity
- unknown
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 29, 2014
- Initial firm notification
- Press Release
- Center classification date
- May 13, 2014