FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Champlain Chocolate Company
- Product
- Lake Champlain chocolates - FIVE STAR BAR 6 PACK - Five Star…
- Reason
- Chocolate may contain plastic pieces
- Published
- February 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Champlain Chocolate Company
- Product
- Gift Baskets 1. Lake Champlain Chocolates - BASKET OF CHEER…
- Reason
- Chocolate may contain plastic pieces
- Published
- February 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Champlain Chocolate Company
- Product
- Milk Chocolate Almond Bark Online stock code: 1Y310-000017-…
- Reason
- Chocolate may contain plastic pieces
- Published
- February 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Champlain Chocolate Company
- Product
- Five Star Bar - Organic Milk Chocolate Bar with Sea Salt & A…
- Reason
- Chocolate may contain plastic pieces
- Published
- February 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Champlain Chocolate Company
- Product
- Chocolates of Vermont 1.Lake Champlain Chocolates - Choco…
- Reason
- Chocolate may contain plastic pieces
- Published
- February 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Champlain Chocolate Company
- Product
- Chocolate Selection (Holiday and regular) 1.Holiday Selec…
- Reason
- Chocolate may contain plastic pieces
- Published
- February 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Champlain Chocolate Company
- Product
- Lake Champlain Chocolates - gift basket- BE MINE; Net Wt. 2l…
- Reason
- Chocolate may contain plastic pieces
- Published
- February 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Champlain Chocolate Company
- Product
- "Lake Champlain Chocolates ***NET WT. 9 oz. (255 g)***a sens…
- Reason
- Chocolate may contain plastic pieces
- Published
- February 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials per tray (NDC 63323-162-01); For IM or IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047.
by Fresenius Kabi USA, LLC
- Reason
- Presence of Particulate Matter - found in reserve sample vials at the firm.
- Published
- February 3, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Phytonadione Tablets 5mg, 30-count bottle, Rx Only, Manufactured For: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA NDC 68682-170-30
by Bausch Health Companies, Inc.
- Reason
- Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
- Published
- February 3, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC Bridgewater, NJ 08807 USA NDC 0187-1704-05
by Bausch Health Companies, Inc.
- Reason
- Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
- Published
- February 3, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Testosterone Cypionate Injection, USP CIII 200mg/ml FOR INTRAMUSCULAR USE ONLY 1mL Single-dose vial Distributed by: Sun Pharma Ind. Inc, NJ 08512 Manufactured by: Sun Pharma Ind. Ltd., India NDC 62756-015-40
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Incorrect Labeling: Incorrect lot number on secondary packaging
- Published
- February 3, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 10.1 fl. oz. (300 ml), Made in China, Distributed by IMC 4284 Shoreline Dr, Spring Park, MN 55384. Labeled as Thrifty White Pharmacy Wash-Free Hand Sanitizer. UPC 8 19845 00599 2
by Shane Erickson Inc
- Reason
- CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
- Published
- February 3, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 3.4 fl. oz. (100 ml), Made in China, Distributed by IMC 4284 Shoreline Dr, Spring Park, MN 55384. Labeled as a) SAFE-GUARD Products International, b) Safe-WAY JEVCO Wash-Free Hand Sanitizer, c) TRACTION CAPITAL, d) United States Census 2020. UPC 8 19845 00598 5
by Shane Erickson Inc
- Reason
- CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
- Published
- February 3, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 1.7 fl. oz. (50 ml) bottles, Distributed by IMC 4284 Shoreline Dr, Spring Park, MN 55384, Made in China, ALSO distributed with Custom front labels as follows a) Sadie G. Mays Health & Rehabilitation Center, b) Pacers logo, c) northwood CHURCH, d) ROGERTHEROOFER.com and e) SoFi Stadium Wash-Free Hand Sanitizer. UPC 8 19845 00597 8
by Shane Erickson Inc
- Reason
- CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
- Published
- February 3, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
EMILIA FOODS SRL
- Product
- Good & Gather Four Cheese Gnocchi, Net Wt. 16 oz. (454g), Ke…
- Reason
- Good and Gather Four Cheese Gnocchi may contain foreign material.
- Published
- February 3, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Nueske Applewood Smoked Meat, Inc
- Product
- Cinnamon Walnut Coffee Cake, Item 258, Net Wt. 24 oz.
- Reason
- Coffee cake may contain undeclared wheat, egg, milk, and walnuts.
- Published
- February 3, 2021
- Distribution
- AR, CA, CO, CT, IA, IL, IN, KY, MD, MI,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Nueske Applewood Smoked Meat, Inc
- Product
- Blueberry Blizzard Coffee Cake, Item 259, Net Wt. 24 oz.
- Reason
- Coffee cake may contain undeclared wheat, egg, and milk.
- Published
- February 3, 2021
- Distribution
- AR, CA, CO, CT, IA, IL, IN, KY, MD, MI,…
View recall →
FDA Recall
Terminated
Historical recordClass II
Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25mg / 0.5ml (22.5mg/ml) 0.5ml per syringe. KEEP FROZEN UNTIL USE AND PROTECT FROM LIGHT SINGLE USE SYRINGE FOR INTRAOCULAR INJECTION Edge Pharma, LLC is an FDA-registered 503B outsourcing facility. This is a compounded (re-packaged) drug. Not for Resale, Hospital/Office use only. Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178
by Edge Pharma, LLC
- Reason
- Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
- Published
- January 27, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
HUMAN CHORIONIC GONADOTROPIN 1,250 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpreserved. Complete Pharmacy & Medical Solutions 5829 NW 158th St, Miami Lakes, FL 33014 Tel: 305-397-2035
by Complete Pharmacy and Medical Solutions, LLC.
- Reason
- CGMP deviations: Lack of potency testing.
- Published
- January 27, 2021
- 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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