Saluta (reduced glutathione) Powder for Injection, 600 mg/vial, packaged in 10 vials per box, Exc...

FDA Drug Recall #D-1318-2014 — Class II — April 29, 2014

Recall Summary

Recall Number D-1318-2014
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

Saluta (reduced glutathione) Powder for Injection, 600 mg/vial, packaged in 10 vials per box, Exclusively Distributed by: QAF Pharmaceuticals Inc. Philippines, Unit Unit 202 ECG Building, Multinational Avenue, Multinational Village, Parahaque City, Metro Manila Philippines; Manufactured by: Shandong Luye Pharmaceutical Co. Ltd, Yantai Shandong, PRC la Luye Pharma Subsidiary, UPC 6920425209014

Reason for Recall

Marketed Without An Approved NDA/ANDA: Parenteral product is labeled for use as an antidote.

Distribution Pattern

Nationwide

Lot / Code Information

Lot #: 201302275, Exp 01/20/15; 201308384, Exp 10/19/2015

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.