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
View recall →
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
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The Kroger Co
- Product
- HomeChef meal kit:Steak and Walnut-Green Onion Sauce with ro…
- Reason
- Supplier provided ingredient (pretzel breading) was SUSPECT for Listeria species, but no further confirmation was performed to confirm the suspect result. Lot number of ingredient in question: 0924032501
- Published
- December 16, 2020
- Distribution
- Alabama, Arizona, Arkansas, California,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The Kroger Co
- Product
- HomeChef meal kit: Buffalo Pretzel Chicken Breast with Roast…
- Reason
- Supplier provided ingredient (pretzel breading) was SUSPECT for Listeria species, but no further confirmation was performed to confirm the suspect result. Lot number of ingredient in question: 0924032501
- Published
- December 16, 2020
- Distribution
- Alabama, Arizona, Arkansas, California,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The Kroger Co
- Product
- HomeChef Meal kit:One-Sheet Pretzel-Crusted Chicken with roa…
- Reason
- Supplier provided ingredient (pretzel breading) was SUSPECT for Listeria species, but no further confirmation was performed to confirm the suspect result. Lot number of ingredient in question: 0924032501
- Published
- December 16, 2020
- Distribution
- Alabama, Arizona, Arkansas, California,…
View recall →
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 I
Kanan Enterprises Inc.
- Product
- On the Go Sweet & Salty Trail Mix
- Reason
- Almonds were found inside packages which do not state they contain almonds.
- Published
- December 16, 2020
- Distribution
- Product distributed in the following sta…
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 →
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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