FDA Recall
Ongoing
Historical recordClass II
Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syringe in 1 CARTON, NDC 63459-910-11, Blister NDC 63459-910-12; (b)10 syringes in 1 CARTON, NDC 63459-910-15, Blister NDC 63459-910-12; (c) 1 syringe in 1 CARTON, NDC 63459-910-17 without safety guard and blister, Rx Only, Manufactured by: UAB Teva Baltics, Vilnius, Lithuania. Distributed by Teva Pharmaceuticals USA, Inc. North Wales PA 19454. Product of Israel.
by Teva Pharmaceuticals USA, Inc
- Reason
- Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
- Published
- February 12, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01, Manufactured for Glenmark Pharmaceuticals, NJ.
by Glenmark Pharmaceuticals Inc., USA
- Reason
- CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
- Published
- February 12, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01, Manufactured for Glenmark Pharmaceuticals, NJ.
by Glenmark Pharmaceuticals Inc., USA
- Reason
- CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
- Published
- February 12, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
la fiesta food products
- Product
- La Fiesta PAN RAYADO SAZONADO Bread Crumbs Seasoned, NET WT…
- Reason
- Firm distributed a Seasoned Bread Crumb product with undeclared allergen (Sesame) not on the label.
- Published
- February 12, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
la fiesta food products
- Product
- La Fiesta PAN RAYADO Bread Crumbs, NET WT 8 OZ. (227g), UPC#…
- Reason
- Firm distributed a Bread Crumb product with undeclared allergen (Sesame) not on the label.
- Published
- February 12, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
FGF, LLC
- Product
- item 8202891 PLAIN VANILLA MINI CAKE DONUT RING BULK 240X1.2…
- Reason
- potential for contamination with listeria monocytogenes
- Published
- February 12, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
FGF, LLC
- Product
- item 8202731 UNFLD BISMARK DONUT PFD 78X3OZ, NET WT 13.16 LB
- Reason
- potential for contamination with listeria monocytogenes
- Published
- February 12, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
FGF, LLC
- Product
- item 8201936 NATURAL & ARTIFICIAL FLAVORED BAVARIAN BISMARK,…
- Reason
- potential for contamination with listeria monocytogenes
- Published
- February 12, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
FGF, LLC
- Product
- item 8201927 APPLE FRITTER DONUT PFD 70 X 3.5OZ, NET WT 13.7…
- Reason
- potential for contamination with listeria monocytogenes
- Published
- February 12, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
FGF, LLC
- Product
- item 8201926 FBALL/EGG SHPD DONUT PFD 78 X 2OZ, NET WT 8.78…
- Reason
- potential for contamination with listeria monocytogenes
- Published
- February 12, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
FGF, LLC
- Product
- item 8201923 BAV CRM BAR DONUT PFD 78 X 3OZ, NET WT 13.16 LB
- Reason
- potential for contamination with listeria monocytogenes
- Published
- February 12, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
FGF, LLC
- Product
- item 8201922 FLAVORED RASPBERRY BISMARK PFD 3OZ, NET WT 13.1…
- Reason
- potential for contamination with listeria monocytogenes
- Published
- February 12, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
FGF, LLC
- Product
- item 8201921 FRENCH CRULLER PFD 72x1.6 OZ, NET WT 6.48 LB
- Reason
- potential for contamination with listeria monocytogenes
- Published
- February 12, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
FGF, LLC
- Product
- item 8201920 APPLE CRISP CK DONUT PFD 78x3OZ, NET WT 13.16 L…
- Reason
- potential for contamination with listeria monocytogenes
- Published
- February 12, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
FGF, LLC
- Product
- item 8201919 BAR YST DONUT UNFLD PFD 74x3OZ, NET WT 12.49 LB
- Reason
- potential for contamination with listeria monocytogenes
- Published
- February 12, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
FGF, LLC
- Product
- item 8201906 JUST BAKED CAKE STICKS 116x2.9 OZ, NET WT 21.03…
- Reason
- potential for contamination with listeria monocytogenes
- Published
- February 12, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
FGF, LLC
- Product
- item 8201905 JUST BAKED BLUEBERRY CAKE RING NATURALLY AND AR…
- Reason
- potential for contamination with listeria monocytogenes
- Published
- February 12, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
FGF, LLC
- Product
- item 8201904 JUST BAKED CHOCOLATE CAKE RINGS ARTIFICIALLY FL…
- Reason
- potential for contamination with listeria monocytogenes
- Published
- February 12, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
FGF, LLC
- Product
- item 8201901 JUST BAKED APPLE CIDER CAKE RINGS WITH NATURAL…
- Reason
- potential for contamination with listeria monocytogenes
- Published
- February 12, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
FGF, LLC
- Product
- item 8201900 APPLE FRITTER DONUT ZGT PFD 54x3OZ, NET WT 9.11…
- Reason
- potential for contamination with listeria monocytogenes
- Published
- February 12, 2025
- 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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