FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Spokane Produce Inc
- Product
- Ham & Cheese sandwich is a Kaiser roll with Ham, American ch…
- Reason
- The sandwiches were made with green leaf and were recalled due to a potential to be contaminated with E. Coli O157:H7.
- Published
- February 13, 2019
- Distribution
- Idaho, Montana, Oregon, Washington, and…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Spokane Produce Inc
- Product
- Red Lettuce Heads, item # 45811, 6 heads are packaged in a b…
- Reason
- The red leaf lettuce heads are recalled due to a potential to be contaminated with E. Coli O157:H7.
- Published
- February 13, 2019
- Distribution
- Idaho, Montana, Oregon, Washington, and…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Willamette Valley Pie Company, LLC.
- Product
- IQF Red Raspberries, packed in flexible poly bags, net wt. 2…
- Reason
- IQF Red Raspberries are recalled due to a potential contamination with Norovirus.
- Published
- February 13, 2019
- Distribution
- ID, CA, OR, TX, and WA.
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Bornstein Seafoods Inc
- Product
- 5-pound cans of unpasteurized, ready-to-eat, Dungeness crab…
- Reason
- 5-pound cans of unpasteurized, reduced oxygen packaged (ROP), ready-to-eat, Dungeness crab meat are recalled because the incorrect Time Temperature Indicator (TTI) was applied to the cans. The TTI would not indicate the temperature abuse. If the product was temperature abused, it would create the potential hazard of Clostridium botulinum growth and toxin formation.
- Published
- February 13, 2019
- Distribution
- CA and OR
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Apple Foods, Inc.
- Product
- Diced Onions, packaged in vacuum sealed clear polybags, 5 po…
- Reason
- Raw diced onions, packaged in vacuum bags, are recalled due to a potential for Clostridium botulinum growth and toxin formation.
- Published
- February 13, 2019
- Distribution
- distributed in Oregon
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Spokane Produce Inc
- Product
- Roast Beef Hoagie sandwich is made with Roast Beef, Processe…
- Reason
- The sandwiches were made with green leaf and were recalled due to a potential to be contaminated with E. Coli O157:H7.
- Published
- February 13, 2019
- Distribution
- Idaho, Montana, Oregon, Washington, and…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Spokane Produce Inc
- Product
- Tuscan Ham sandwich is a Hoagie bread made with Ham, Process…
- Reason
- The sandwiches were made with green leaf and were recalled due to a potential to be contaminated with E. Coli O157:H7.
- Published
- February 13, 2019
- Distribution
- Idaho, Montana, Oregon, Washington, and…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Spokane Produce Inc
- Product
- Turkey Swiss sandwich is a Kaiser Roll with Turkey, Swiss Ch…
- Reason
- The sandwiches were made with green leaf and were recalled due to a potential to be contaminated with E. Coli O157:H7.
- Published
- February 13, 2019
- Distribution
- Idaho, Montana, Oregon, Washington, and…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Spokane Produce Inc
- Product
- Turkey Bacon Cheddar sandwiches were made with Turkey, Bacon…
- Reason
- The sandwiches were made with green leaf and were recalled due to a potential to be contaminated with E. Coli O157:H7.
- Published
- February 13, 2019
- Distribution
- Idaho, Montana, Oregon, Washington, and…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Spokane Produce Inc
- Product
- -Washed and Packed Whole Green Lettuce Fillets, item # 80415…
- Reason
- The green leaf lettuce fillets and heads are recalled due to a potential to be contaminated with E. Coli O157:H7.
- Published
- February 13, 2019
- Distribution
- Idaho, Montana, Oregon, Washington, and…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Spokane Produce Inc
- Product
- Italian Tapenade sandwich is Hoagie sandwich made with peppe…
- Reason
- The sandwiches made with green leaf are recalled due to a potential to be contaminated with E. Coli O157:H7.
- Published
- February 13, 2019
- Distribution
- Idaho, Montana, Oregon, Washington, and…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Century Snacks LLC
- Product
- Snak Club Tajin Chili & Lime Peanuts Mild 5 oz. Produced B…
- Reason
- Undeclared allergen; tree nuts.
- Published
- February 13, 2019
- Distribution
- U.S. distribution to the following: AZ,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Funky Chunky LLC
- Product
- Nutty Choco Pop, 10 oz. bag. Sold in the following configur…
- Reason
- Nutty Choco Pop has in incorrect label and does not declare that it contains cashews and almonds.
- Published
- February 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0378-0782-93) and b) 500-count bottles (NDC 0378-0782-05); Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA.
by Mylan Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was slightly elevated above specification.
- Published
- February 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
BromSite (bromfenac ophthalmic solution) 0.075%, 5 mL bottles, Rx Only, Distributed by : Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 49708-754-41
by Sun Pharmaceutical Industries, Inc.
- Reason
- Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.
- Published
- February 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00
by H J Harkins Company Inc dba Pharma Pac
- Reason
- Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.
- Published
- February 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only, Manufactured by: Akorn, Inc. Lake Forest, IL 60045, NDC 17478-283-10
by Akorn, Inc.
- Reason
- Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.
- Published
- February 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Irbesartan and Hydrochlorothiazide Tablets, USP 150/12.5 mg Rx 30 Tablets Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zheijang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 NDC 43547-330-03
by Prinston Pharmaceutical Inc
- Reason
- CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
- Published
- February 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zheijang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 90 count NDC 43547-331-09
by Prinston Pharmaceutical Inc
- Reason
- CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
- Published
- February 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zheijang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 30 count - NDC 43547-331-03
by Prinston Pharmaceutical Inc
- Reason
- CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
- Published
- February 6, 2019
- 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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