FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Fusion Health and Vitality LLC
- Product
- PHARMORIGINS CORE with Natural Orange Flavor NATURAL ENERGY…
- Reason
- The firm is recalling their products due the unapproved use of a food additive and unapproved marketing statements
- Published
- December 23, 2020
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor), packaged in cartons of 50 cartridges (1.7 mL each), Rx only, Manufactured for SEPTODONT, Inc., Louisville, CO 80027, by Novocol Pharmaceutical of Canada, Inc., Cambridge, ON N1R 6X3, Canada, NDC 0362-1098-90
by Novocol Pharmaceutical of Canada, Inc.
- Reason
- Labeling: Label mix-up
- Published
- December 16, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Docetaxel Injection USP 160 mg/8mL (20 mg/mL), For Intravenous Infusion Only, Rx Only, 8 mL Single Use Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, NDC 72485-216-08.
by Shilpa Medicare Limited
- Reason
- CGMP Deviations
- Published
- December 16, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals Inc., Manalapan, NJ 07726, NDC 72485-203-30.
by Shilpa Medicare Limited
- Reason
- CGMP Deviations
- Published
- December 16, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals Inc., Manalapan, NJ 07726, NDC 72485-202-90.
by Shilpa Medicare Limited
- Reason
- CGMP Deviations
- Published
- December 16, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, NDC 72606-558-01.
by Shilpa Medicare Limited
- Reason
- CGMP Deviations
- Published
- December 16, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, Jadcherla, 509301, India, Distributed by: Armas Pharmaceuticals, Inc. Manalapan, NJ 07726 NDC 72485-201-01.
by Shilpa Medicare Limited
- Reason
- CGMP Deviations
- Published
- December 16, 2020
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must be diluted before use, Single Dose Vial, Sterile, Cytotoxic Agent, Rx Only, 10 mL vial, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, Vial NDC 72485-210-01, Carton NDC 72485-210-08.
by Shilpa Medicare Limited
- Reason
- CGMP Deviations
- Published
- December 16, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL Single Dose Bottle, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-671-05
by Fresenius Kabi USA, LLC
- Reason
- Cross Contamination with other products: trace amounts of lidocaine
- Published
- December 16, 2020
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
JMH International, LLC
- Product
- Chef Myron's Premium Shoyu Sauce, 1 GAL (3.78 L), Item # 400…
- Reason
- Product utilized a gluten-free claim but has as an ingredient a fermented soy sauce that is produced from wheat which was not processed to remove the gluten prior to fermentation.
- Published
- December 16, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
JMH International, LLC
- Product
- Chef Myron's Yakitori Sauce, 64 FL OZ (1.89 L), Item # 4000…
- Reason
- Product utilized a gluten-free claim but has as an ingredient a fermented soy sauce that is produced from wheat which was not processed to remove the gluten prior to fermentation.
- Published
- December 16, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
JMH International, LLC
- Product
- Chef Myron's Tsukeyaki Sauce, 64 FL OZ (1.89 L), Item # 4000…
- Reason
- Product utilized a gluten-free claim but has as an ingredient a fermented soy sauce that is produced from wheat which was not processed to remove the gluten prior to fermentation.
- Published
- December 16, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
JMH International, LLC
- Product
- Chef Myron's Tangy Teriyaki Sauce, 64 FL OZ (1.89 L), Item #…
- Reason
- Product utilized a gluten-free claim but has as an ingredient a fermented soy sauce that is produced from wheat which was not processed to remove the gluten prior to fermentation.
- Published
- December 16, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
JMH International, LLC
- Product
- Chef Myron's Szechuan Sauce, 64 FL OZ (1.89 L), Item # 40002…
- Reason
- Product utilized a gluten-free claim but has as an ingredient a fermented soy sauce that is produced from wheat which was not processed to remove the gluten prior to fermentation.
- Published
- December 16, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
JMH International, LLC
- Product
- Chef Myron's Premium Teriyaki Sauce, 64 FL OZ (1.89 L), Item…
- Reason
- Product utilized a gluten-free claim but has as an ingredient a fermented soy sauce that is produced from wheat which was not processed to remove the gluten prior to fermentation.
- Published
- December 16, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
JMH International, LLC
- Product
- Chef Myron's Ponzu Sauce, 64 FL OZ (1.89 L), Item # 40002311…
- Reason
- Product utilized a gluten-free claim but has as an ingredient a fermented soy sauce that is produced from wheat which was not processed to remove the gluten prior to fermentation.
- Published
- December 16, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
JMH International, LLC
- Product
- Chef Myron's Eurasian Fusion Sauce, 64 FL OZ (1.89 L), Item…
- Reason
- Product utilized a gluten-free claim but has as an ingredient a fermented soy sauce that is produced from wheat which was not processed to remove the gluten prior to fermentation.
- Published
- December 16, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Riverside Natural Foods, Ltd.
- Product
- Good & Gather Banana Chocolate Chip Date & Nut Bars, UPC 0 8…
- Reason
- The product contains an undeclared almonds.
- Published
- December 16, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Anagrelide Capsules, USP 1 mg, 100 capsules, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ 07920 NDC 13668-462-01
by Torrent Pharma Inc
- Reason
- Failed Dissolution Specifications
- Published
- December 9, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Clobetasol Propionate Ointment USP 0.05%, Net Wt. 50 grams, Rx Only, Teligent Pharma. Inc. Buena, NJ 08310 NDC 52565-039-60
by Teligent Pharma, Inc.
- Reason
- Superpotent and Subpotent; low and high assay results
- Published
- December 9, 2020
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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