Opto-Pharm Pte Ltd. · 66-41 · SINGAPORE
For Opto-Pharm Pte Ltd. · 66-41 · SINGAPORE, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is SINGAPORE; product code is 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 09/30/2009; address is 13 Tuas Avenue 12 , Singapore, SINGAPORE, verified against its source on 2026-09-16.
- Firm
- Opto-Pharm Pte Ltd. verified
- Import alert
- 66-41
- Import alert name
- Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- Country
- SINGAPORE verified
- Address
- 13 Tuas Avenue 12 , Singapore, SINGAPORE verified
- Date published
- 09/30/2009 verified
- Product code
- 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. each item verified
- FDA notes
- Orto eyes is labeled as a dietary supplement and as a protectant against eye irritation or to relieve dryness of the eye. Based on its route of administration (opthamalic); this product does not qualify as a dietary supplement because it is not ingested. In addition; the website www.aor.ca that describes Ortho Eyes product; promotes one of its ingrediants N-acetyl-carnosine to improve eyesite; treat corneal dtsrophy; corneal trophic keratitus and bullous keratopathy. Based on its intended uses this product is a drug. Further; we are not aware of anyth substantial scientific evidence that this product is generally recognized as safe and effective for the conditions recommended or suggested on its labeling. | Ortho eyes is labeled as a dietary supplement and as a protectant against eye irritation or to relieve dryness of the eye. Based on its route of administration (opthamalic); this product does not qualify as a dietary supplement because it is not ingested. In addition; the website www.aor.ca that describes Ortho Eyes product; promotes one of its ingrediants N-acetyl-carnosine to improve eyesite; treat corneal dtsrophy; corneal trophic keratitus and bullous keratopathy. Based on its intended uses this product is a drug. Further; we are not aware of anyth substantial scientific evidence that this product is generally recognized as safe and effective for the conditions recommended or suggested on its labeling. each item verified
What the source says
Opto-Pharm Pte Ltd. Date Published : 09/30/2009 13 Tuas Avenue 12 , Singapore, SINGAPORE 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 09/30/2009 Notes: Orto eyes is labeled as a dietary supplement and as a protectant against eye irritation or to relieve dryness of the eye. Based on its route of administration (opthamalic); this product does not qualify as a dietary supplement because it is not ingested. In addition; the website www.aor.ca that describes Ortho Eyes product; promotes one of its ingrediants N-acetyl-carnosine to improve eyesite; treat corneal dtsrophy; corneal trophic keratitus and bullous keratopathy. Based on its intended uses this product is a drug. Further; we are not aware of anyth substantial scientific evidence that this product is generally recognized as safe and effective for the conditions recommended or suggested on its labeling. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 09/30/2009 Notes: Ortho eyes is labeled as a dietary supplement and as a protectant against eye irritation or to relieve dryness of the eye. Based on its route of administration (opthamalic); this product does not qualify as a dietary supplement because it is not ingested. In addition; the website www.aor.ca that describes Ortho Eyes product; promotes one of its ingrediants N-acetyl-carnosine to improve eyesite; treat corneal dtsrophy; corneal trophic keratitus and bullous keratopathy. Based on its intended uses this product is a drug. Further; we are not aware of anyth substantial scientific evidence that this product is generally recognized as safe and effective for the conditions recommended or suggested on its labeling.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
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