Class II · Moderate risk
Clear Eyes Redness Relief
Lack of Assurance of Sterility
Te Xiao BaiNeiTing Herbal Supplement
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Cause type: Unapproved drug
The product was marketed without an approved NDA/ANDA, or does not meet the OTC monograph it claims to follow. Nothing about the product - dose, purity, safety - has been reviewed by FDA, so the claims on the box are unverified. All unapproved drug recalls.
What was recalled
Te Xiao BaiNeiTing Herbal Supplement (Naphazoline HCl Solution 0.1%) liquid, Net Wt. 15ml, packaged in a bottle within a box, Produced by: Good Harvests (Asia) Trading Co., Ltd, Imported by Murray Int'l Trading Co., Inc. New York, NY 10013, UPC 7 67533 86115 6, remaining labeling contains Chinese characters.
Drug: Naphazoline
- Recalling firm
- Murray International Trading Co., Inc.
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1357-2016 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Naphazoline recalls
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Class II · Moderate risk
Clear Eyes Redness Relief
Lack of Assurance of Sterility
Class II · Moderate risk
Rohto Cooling Eye Drops Cool Relief
Lack of Assurance of Sterility
Class II · Moderate risk
Rohto Cooling Eye Drops Optic Glow
Lack of Assurance of Sterility
Class II · Moderate risk
Rohto Cooling Eye Drops Max Strength
Lack of Assurance of Sterility
Other recalls by Murray International Trading Co., Inc.
All 2016 recalls
Class II · Moderate risk
Fuqingsong Relief Cream
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Class II · Moderate risk
Ping on Ointment Relief for Muscular Pain
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
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Farser Kai Yeung Pill
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Class II · Moderate risk
Wupooser Kai Yeung Pill
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
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