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Collagen and Gelatin Export Lists
… On this page: Collagen vs. Gelatin Additional Documentation Additional Information on Collagen and Gelatin Exports to the EU Additional Information on Collagen and Gelatin Exports to the UK U.S. export of …
Bloommy, Inc Issues Allergy Alert on Undeclared Fish in Bloommy Biotin Collagen Keratin Capsules
… product due to the presence of a fish allergen for the collagen-based ingredient. The best by involved or purchase … reaction if they consume these products. Bloommy Biotin Collagen Keratin Capsules for Skin, Joint, and Hair, 60 … supplement label stating the presence of fish in the fish collagen product of Bloommy Biotin Collagen Keratin Capsules …
MACI (autologous cultured chondrocytes on porcine collagen membrane)
… Proper Name: autologous cultured chondrocytes on porcine collagen membrane Tradename: MACI Manufacturer: Vericel … … MACI (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold … … MACI (autologous cultured chondrocytes on porcine collagen membrane) …
Bulletproof 360, Inc. Recalls Collagen Protein Bars and Bites Because of Possible Health Risk
… (“Bulletproof”) of Bellevue, Washington is recalling five Collagen Protein Bar and Bite products because they have the … UPC Box UPC Use by Dates Lot numbers Fudge Brownie Collagen Protein Bar Individually packed in foil wrappers, … Fudge Brownie Collagen Protein Bite Individually packed in foil wrappers, …
Bulletproof 360, Inc. Issues Allergy Alert on Undeclared Milk in Collagen Protein Dietary Supplement
… is voluntarily recalling one lot #1017088 of Bulletproof Collagen Protein dietary supplement due to undeclared milk. … consume this product. The recalled product is Bulletproof Collagen Protein dietary supplement, packaged in a 16-oz. … expires by March 2019. All other lots of Bulletproof Collagen Protein and other products purchased at …
BUBS Naturals is Recalling Two Lots of Fountain of Youth Collagen Powder After Firm Testing Found Milk Protein in The Product That Uses MCT Powder Oil as an Ingredient
… recalling certain lots of its Fountain of Youth Formula Collagen Protein (“Fountain of Youth Product”) due to … recalling certain lots of its Fountain of Youth Formula Collagen Protein (“Fountain of Youth Product”) due to … … BUBS Naturals is Recalling Two Lots of Fountain of Youth Collagen Powder After Firm Testing Found Milk Protein in The …
European Union (EU) Bulk Gelatin and Collagen Products Shipper's List
… Seafoods, Inc. 551 W. Broadway Un Alaska AK PP fish Collagen 10874603768 Lonza Fort Smith 1302 Jackson Street Fort Smith AR PP Collagen 3011470852 Phoenix Formulations Tempe AR PP B Collagen 3010235361 Supreme Formulations San Nutrition 2400 …
Collagen Matrix, Inc. - 496451 - 11/01/2017
… MA 02180 November 1, 2017 Bareld J. Doedens CEO Collagen Matrix, Inc. 15 Thornton Road Oakland, NJ 07436 Dear … … CGMP/QSR/Medical Devices/Adulterated … Medical Devices … Collagen Matrix, Inc. - 496451 - 11/01/2017 …
GINTUIT (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen)
… Cultured Keratinocytes and Fibroblasts in Bovine Collagen Trade Name: GINTUIT Manufacturer: Organogenesis … Cultured Keratinocytes and Fibroblasts in Bovine Collagen) …
ELM Update and Reminder to Firms Exporting Collagen, Gelatin, or Seafood Products to the European Union
… U.S. establishments that are currently included on the EU collagen, gelatin, or seafood export lists should submit … country requirements for dairy , infant formula , collagen , gelatin , and seafood products. Foreign … and infant formula to China and establishments exporting collagen and gelatin products to the European Union. To …
VYJUVEK
… dystrophic epidermolysis bullosa with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene. Product … dystrophic epidermolysis bullosa with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene. … Biologics … …
FDA Approves First Topical Gene Therapy for Treatment of Wounds in Patients with Dystrophic Epidermolysis Bullosa
… epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene. “Vyjuvek is … mutation(s) in the COL7A1 gene. This gene encodes type VII collagen (COL7), which is an essential protein that helps … dystrophic epidermolysis bullosa with mutation(s) in the collagen type VII alpha 1 chain gene. … Biologics … FDA …
FDA approves first autologous cellularized scaffold for the repair of cartilage defects of the knee
… approved Maci (autologous cultured chondrocytes on porcine collagen membrane) for the repair of symptomatic, … (can be broken down by the body) porcine-derived collagen membrane that is implanted over the area where the … approved Maci (autologous cultured chondrocytes on porcine collagen membrane) for the repair of symptomatic, …
FDA approves Integra Omnigraft Dermal Regeneration Matrix to treat diabetic foot ulcers
… ulcers. The matrix device, which is made of silicone, cow collagen, and shark cartilage, is placed over the ulcer and … not be used in patients with allergies to cow (bovine) collagen or chondroitin (cartilage from any source) since … ulcers. The matrix device, which is made of silicone, cow collagen, and shark cartilage, is placed over the ulcer and …
Herbalife International Of America, Inc. Issues Voluntary Recall For Its Protein Bar – Peanut Butter Due To Trace Amounts Of Undeclared Fish Allergen
… (approximately 0.02%). The gelatin is a highly processed collagen from fish skin, which contains a negligible amount … (approximately 0.02%). The gelatin is a highly processed collagen from fish skin, which contains a negligible amount …
June 29, 2017 PREA Non-Compliance - Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen (GINTUIT)
… Cultured Keratinocytes and Fibroblasts in Bovine Collagen (GINTUIT). The Agency has determined that you have … Cultured Keratinocytes and Fibroblasts in Bovine Collagen (GINTUIT) …
Great Lakes Gelatin Company - 612323 - 05/10/2021
… has determined that you take orders there for the products Collagen Hydrolysate (10 oz unflavored and vanilla, mixed … Pack (20 count unflavored), 8lb unflavored), Keto Collagen + MCT, and Collagen Endurance Plus. We have also reviewed your social …
Molecular BioLife International, Inc. - 612629 - 04/15/2021
… that you take orders there for the products Shark 2 Collagen and Balanced Kollagen. The claims on your website … products are intended for use as drugs include: Shark 2 Collagen The Latest Research page on your website says, “Click Here for More Information About Shark 2 Collagen,” which links to a white paper about Shark 2 …
Applied Health Solutions, Inc. - 616778 - 10/22/2021
… joint-soft-tissue-support/products/cellrenew-pro-hydrolyzed-collagen-type-ii): • “CellRenew PRO provides … and monograph webpages: • “CellRenew contains Hydrolyzed Collagen Type II derived from 100% pure chicken sternal … Hyaluronic Acid and Chondroitin Sulfates, Collagen Type II is easily absorbed to restore joint and …
Biomedical Research Laboratories, LLC - 612831 - 07/01/2021
… at https://nativeorigins.com for your Calm Legs, Flexify, Collagen Peptides, Prohemia, Altitude RX, and Trimmunity … of osteoarthritis or preventing it completely.” Collagen Peptides On your product website https://nativeorigins.com: • On the Collagen Peptides product page: o “Some studies have …
Induction Therapies, LLC - 616487 - 11/23/2021
… (FDA) determined that your firm is a manufacturer of Collagen P.I.N., a microneedling product. Under section … body. The agency has reviewed the product labeling for the Collagen P.I.N, including brochures, pamphlets, and your … This review revealed statements that establish that the Collagen P.I.N. is intended for use in the diagnosis of …
STRATAGRAFT
… cultured keratinocytes and dermal fibroblasts in murine collagen-dsat Tradename: STRATAGRAFT Manufacturer: Stratatech … cultured keratinocytes and dermal fibroblasts in murine collagen- dsat Refer to Section 1.1 of the Clinical Review …
Orphic Nutrition - 612470 - 04/13/2021
… Ashwagandha Capsules, Garcinia Cambogia Capsules, Premium Collagen Peptides Capsules, Elderberry Gummies, Omega 3 Fish … effective against the bacteria Tuberculosis.” Premium Collagen Peptides Capsules On your webpage titled “THE TYPES … ://orphicnutrition.com/blogs/news/the-types-and-benefits-of-collagen-peptides-a-complete-guide), where you display a …
New York Nutrition Company / American Metabolix - 611994 - 08/31/2021
… Muscle Test, Banish, Ketogenic Diet Aid, Keto Friendly Collagen, Exile Euphoric Weight Loss, Exile Super Shock, … Muscle Test, Banish, Ketogenic Diet Aid, and Keto Friendly Collagen products are drugs under section 201(g)(1)(B) of the … that it can help address thyroid disorders.” Keto Friendly Collagen On your product page for Keto Friendly Collagen at …
Approved Cellular and Gene Therapy Products
… Cultured Keratinocytes and Fibroblasts in Bovine Collagen) Organogenesis Incorporated HEMACORD (HPC, cord … Inc. MACI (Autologous Cultured Chondrocytes on a Porcine Collagen Membrane) Vericel Corp. OMISIRGE (omidubicel-onlv) … cultured keratinocytes and dermal fibroblasts in murine collagen-dsat) Stratatech Corporation TECARTUS …