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,…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
O & H DANISH BAKERY
- Product
- O H Danish Bakery Almond Danish Kringle, UPC 67209-00006. N…
- Reason
- Almond Kringle may contain undeclared Pecans.
- Published
- February 3, 2021
- Distribution
- Sold at Trader Joe's retail stores in th…
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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 →
FDA Recall
Terminated
Historical recordClass II
HUMAN CHORIONIC GONADOTROPIN 5,000 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 →
FDA Recall
Terminated
Historical recordClass II
HUMAN CHORIONIC GONADOTROPIN 6,000 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 →
FDA Recall
Terminated
Historical recordClass II
HUMAN CHORIONIC GONADOTROPIN 11,000 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
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FDA Recall
Terminated
Historical recordClass II
Refresh Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz (10 mL) Sterile Distributed by: Allergan, an AbbVie company Madison, NJ 07940 UPC 3 00236 63410 0, NDC 0023-6634-10.
by Allergan, PLC.
- Reason
- Labeling: Missing instructions for use insert
- Published
- January 27, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per carton (10 capsules x 10 blister cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC Carton: 68084-446-01; NDC Blister Card: 68084- 446-11
by American Health Packaging
- Reason
- Failed Dissolution Specifications
- Published
- January 27, 2021
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
JTM Provisions Co Inc
- Product
- JTM FOOD GROUP brand READY TO EAT WHITE CHEDDAR MACARONI & C…
- Reason
- Possible metal shavings.
- Published
- January 27, 2021
- Distribution
- Product was distributed to the following…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
GH Foods CA LLC
- Product
- Spinach and Orzo Pasta Kit 2/5 lb. UPC: 20826766840209 So…
- Reason
- Contain Eggs was not listed on scale label printed at retail stores. Label does state that the product May contain any of the eight allergen that are listed out on the label,
- Published
- January 27, 2021
- Distribution
- Whole Foods distribution to CA and CO DC…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
GH Foods CA LLC
- Product
- Spinach and Basil Pasta Salad Kit 2/5 lb. UPC: 20826766811…
- Reason
- Contain Eggs was not listed on scale label printed at retail stores. Label does state that the product May contain any of the eight allergen that are listed out on the label,
- Published
- January 27, 2021
- Distribution
- Whole Foods distribution to CA and CO DC…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
GH Foods CA LLC
- Product
- Smoked Mozzarella Pasta Salad Kit 2/5 lb. UPC: 20826766840…
- Reason
- Contain Eggs was not listed on scale label printed at retail stores. Label does state that the product May contain any of the eight allergen that are listed out on the label,
- Published
- January 27, 2021
- Distribution
- Whole Foods distribution to CA and CO DC…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
GH Foods CA LLC
- Product
- Italian Pasta Salad Kit 2/5 lb. UPC: 20826766811377 Sold…
- Reason
- Contain Eggs was not listed on scale label printed at retail stores. Label does state that the product May contain any of the eight allergen that are listed out on the label,
- Published
- January 27, 2021
- Distribution
- Whole Foods distribution to CA and CO DC…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
GH Foods CA LLC
- Product
- Pesto Pasta Salad Kit 2/5 lb. Keep refrigerated UPC: 8267…
- Reason
- Contain Eggs was not listed on scale label printed at retail stores. Label does state that the product May contain any of the eight allergen that are listed out on the label,
- Published
- January 27, 2021
- Distribution
- Whole Foods distribution to CA and CO DC…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
GH Foods CA LLC
- Product
- Asian Noodle Salad Kit 2/5 lb. Keep refrigerated Amazon U…
- Reason
- Contain Eggs was not listed on scale label printed at retail stores. Label does state that the product May contain any of the eight allergen that are listed out on the label,
- Published
- January 27, 2021
- Distribution
- Whole Foods distribution to CA and CO DC…
View recall →
FDA Recall
Terminated
Historical recordClass III
Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups, Rx Only, Genus Lifesciences Inc. NDC 64950-354-05 Case NDC: 64950-354-450(40 unit dose cups) Case NDC 64950-354-55 (50 unit dose cups)
by Genus Lifesciences Inc.
- Reason
- Presence of Foreign Substance: Particulate matter was found in multiple lots of product.
- Published
- January 20, 2021
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Chlorhexidine Gluconate Oral Rinse USP 0.12%, packaged in a) 15 mL x 30 Unit Dose Cups (30-pack case) NDC 68094-028-61, b) 15 mL x 100 Unit Dose Cups (100-pack case) NDC 68094-028-62, Rx only, Precision Dose, Inc., South Beloit, IL 61080.
by Precision Dose Inc.
- Reason
- cGMP deviations: The firm was notified of the manufacturer's expanded recall.
- Published
- January 20, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120, NDC: 29033-056-01
by Nostrum Laboratories Inc
- Reason
- CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
- Published
- January 20, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml (25mg/ml), 5 mL per syringe, Rx Only, SYRINGE FOR IM INJECTION, Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178, Barcode 0544650505
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 20, 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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