FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
The Smokehouse of New York, LLC.
- Product
- Refrigerated, ready-to-eat, sliced, whole, split, hot SMOKED…
- Reason
- The products have the potential to be contaminated with Listeria monocytogenes based on FDA sampling and analysis. During an FDA inspection, an environmental sample (973983) was collected and submitted to NRL for analysis. NRL's analysis revealed 37 out of 99 subs were positive for L. monocytogenes including both Zone 1 and Zone 2 locations.
- Published
- June 7, 2017
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
The Smokehouse of New York, LLC.
- Product
- Refrigerated, ready-to-eat, hot SMOKED STURGEON, HAND SLICED…
- Reason
- The products have the potential to be contaminated with Listeria monocytogenes based on FDA sampling and analysis. During an FDA inspection, an environmental sample (973983) was collected and submitted to NRL for analysis. NRL's analysis revealed 37 out of 99 subs were positive for L. monocytogenes including both Zone 1 and Zone 2 locations.
- Published
- June 7, 2017
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
The Smokehouse of New York, LLC.
- Product
- Refrigerated, ready-to-eat, sliced, hot SMOKED TROUT fillet…
- Reason
- The products have the potential to be contaminated with Listeria monocytogenes based on FDA sampling and analysis. During an FDA inspection, an environmental sample (973983) was collected and submitted to NRL for analysis. NRL's analysis revealed 37 out of 99 subs were positive for L. monocytogenes including both Zone 1 and Zone 2 locations.
- Published
- June 7, 2017
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
The Smokehouse of New York, LLC.
- Product
- Refrigerated, ready-to-eat, sliced, cold smoked salmon, CHOP…
- Reason
- The products have the potential to be contaminated with Listeria monocytogenes based on FDA sampling and analysis. During an FDA inspection, an environmental sample (973983) was collected and submitted to NRL for analysis. NRL's analysis revealed 37 out of 99 subs were positive for L. monocytogenes including both Zone 1 and Zone 2 locations.
- Published
- June 7, 2017
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
The Smokehouse of New York, LLC.
- Product
- Refrigerated, ready-to-eat, sliced, cold smoked, GRAVLAX SAL…
- Reason
- The products have the potential to be contaminated with Listeria monocytogenes based on FDA sampling and analysis. During an FDA inspection, an environmental sample (973983) was collected and submitted to NRL for analysis. NRL's analysis revealed 37 out of 99 subs were positive for L. monocytogenes including both Zone 1 and Zone 2 locations.
- Published
- June 7, 2017
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
The Smokehouse of New York, LLC.
- Product
- Refrigerated, ready-to-eat, sliced, cold smoked, PASTRAMI SM…
- Reason
- The products have the potential to be contaminated with Listeria monocytogenes based on FDA sampling and analysis. During an FDA inspection, an environmental sample (973983) was collected and submitted to NRL for analysis. NRL's analysis revealed 37 out of 99 subs were positive for L. monocytogenes including both Zone 1 and Zone 2 locations.
- Published
- June 7, 2017
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
The Smokehouse of New York, LLC.
- Product
- Refrigerated, ready-to-eat, sliced, cold smoked, IMPORTED SC…
- Reason
- The products have the potential to be contaminated with Listeria monocytogenes based on FDA sampling and analysis. During an FDA inspection, an environmental sample (973983) was collected and submitted to NRL for analysis. NRL's analysis revealed 37 out of 99 subs were positive for L. monocytogenes including both Zone 1 and Zone 2 locations.
- Published
- June 7, 2017
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
The Smokehouse of New York, LLC.
- Product
- Refrigerated, ready-to-eat, sliced, cold smoked, DOUBLE SMO…
- Reason
- The products have the potential to be contaminated with Listeria monocytogenes based on FDA sampling and analysis. During an FDA inspection, an environmental sample (973983) was collected and submitted to NRL for analysis. NRL's analysis revealed 37 out of 99 subs were positive for L. monocytogenes including both Zone 1 and Zone 2 locations.
- Published
- June 7, 2017
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
The Smokehouse of New York, LLC.
- Product
- Refrigerated, ready-to-eat, sliced, cold smoked, SMOKED NORW…
- Reason
- The products have the potential to be contaminated with Listeria monocytogenes based on FDA sampling and analysis. During an FDA inspection, an environmental sample (973983) was collected and submitted to NRL for analysis. NRL's analysis revealed 37 out of 99 subs were positive for L. monocytogenes including both Zone 1 and Zone 2 locations.
- Published
- June 7, 2017
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Tyson Foods, inc.
- Product
- Sara Lee CP Quiche 10 Spinach , 38 oz. packed in a paper car…
- Reason
- The firm is voluntarily recalling multiple lots of frozen Chef Pierre 10 Spinach Quiche, Chef Pierre 6/10 Frozen Quiche, and Sara Lee CP Quiche 10 Spinach following an ingredient supplier's recall due to Listeria monocytogenes.
- Published
- June 7, 2017
- Distribution
- Domestic only: FL,GA, IA, IL, KY, TX, MI…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Tyson Foods, inc.
- Product
- Chef Pierre 10 Spinach Quiche, and 6/10 Frozen Quiche, 38 oz…
- Reason
- The firm is voluntarily recalling multiple lots of frozen Chef Pierre 10 Spinach Quiche, Chef Pierre 6/10 Frozen Quiche, and Sara Lee CP Quiche 10 Spinach following an ingredient supplier's recall due to Listeria monocytogenes.
- Published
- June 7, 2017
- Distribution
- Domestic only: FL,GA, IA, IL, KY, TX, MI…
View recall →
FDA Recall
Terminated
Historical recordClass I
LaBri's Body Health Atomic, 60 capsules
by Envy Me
- Reason
- Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine.
- Published
- May 31, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Shield and Protect Moisture Barrier Cream, 1.1% Clotrimazole, Net Weight 4 oz - 115 g Anti-Fungal, Gentell, Inc., Bristol, PA NDC 61554-232-40
by Gentell, Inc
- Reason
- GMP Deviations; product may not meet cGMP requirements
- Published
- May 31, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Hyland's Baby Nighttime Teething Tablets [Belladonna 12X HPUS (0.0000000000003% alkaloids, calculated), Calcarea Phosphorica 6X HPUS, Chamomilla 6X HPUS, Coffea Cruda 6X HPUS, Magnesia Phosphorica 6X HPUS, Rheum 6X HPUS, Silicea 12X HPUS] Quick-Dissolving Tablets, 135-count bottle, Manufactured for: Hyland's, Inc., Los Angesles, CA 90061, NDC 54973-3197-1, UPC 3 54973 31971 4.
by Standard Homeopathic Company
- Reason
- Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels.
- Published
- May 31, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
HYDROCORTISONE LOTION, USP, 2.5%, 2 FL OZ (59 mL) bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-7785-52.
by Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals
- Reason
- Superpotent Drug: above specification for the assay.
- Published
- May 31, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Children's Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30-count bottle, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol - 389 350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 47335-343-83.
by Sun Pharmaceutical Industries, Inc.
- Reason
- Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.
- Published
- May 31, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sodium Phosphate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
by Advanced Pharma Inc.
- Reason
- Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- Published
- May 31, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dexamethasone Sodium Phosphate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
by Advanced Pharma Inc.
- Reason
- Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- Published
- May 31, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Bumetadine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
by Advanced Pharma Inc.
- Reason
- Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- Published
- May 31, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Glycopyrrolate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
by Advanced Pharma Inc.
- Reason
- Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- Published
- May 31, 2017
- 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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