FDA Recall
Terminated
Historical recordClass III
Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx Only, 7.5 mL bottle, Manufactured by: Lupin Limited, Pithampur (M.P.), INDIA, NDC: 68180-429-03.
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.
- Published
- January 8, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Silver Bullet, Get Bigger and Harder, Works in Minutes, Lasts for Days, 10 male enhancement capsules in blister foil package, 725mg per capsule, Distributed by Silver Bullet Ltd, Golden Springs, CO, USA, UPC: 610877392698.
by Natures Rx
- Reason
- Marketed Without an Approved NDA/ANDA; Product contains undeclared active ingredient - Sildenafil.
- Published
- January 8, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio. (a) Case of 50 cups (NDC 60687-260-69) (b) Case of 40 cups (NDC 60687-260-23 (c) Unit Dose Cup (NDC 60687-260-69)
by American Health Packaging
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Published
- January 8, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
SARA LEE FROZEN FOODS
- Product
- Chef Pierre 37 Ounce Pumpkin Spice Latte Pie, in foil pie pa…
- Reason
- undeclared FD & C Red 40
- Published
- January 8, 2020
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol; Oestriol] Micronized, USP, CAS 50-27-1, packaged in a) 1 G glass bottles, b) 5 G glass bottles, c) 25 G glass bottles, d) 100 G glass bottles, e) 500 G glass bottles, and f) 1 KG plastic bottles, Rx Only, Spectrum Chemical Mfg Corp., Gardena, CA 90248.
by Spectrum Laboratory Products
- Reason
- Subpotent Drug: Supplier indicated assay results did not meet specifications.
- Published
- January 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
NORepinephrine Bitartrate 4 mg added to 250 mL 5% Dextrose Injection USP (16 mcg per mL) Total Volume 254.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.
by PharMEDium Services, LLC
- Reason
- Subpotent Drug
- Published
- January 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
NORepinephrine Bitartrate 8 mg added to 500 mL 5% Dextrose Injection USP (16 mcg per mL) Total Volume 508.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.
by PharMEDium Services, LLC
- Reason
- Subpotent Drug
- Published
- January 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
NORepinephrine Bitartrate 8 mg added to 250 mL 5% Dextrose Injection USP (32 mcg per mL) Total Volume 258.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.
by PharMEDium Services, LLC
- Reason
- Subpotent Drug
- Published
- January 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Fuji Food Products, Inc.
- Product
- Trader Joes Queso Fundido 16oz, SKU 646574
- Reason
- RTE products potentially contaminated with Listeria monocytogenes.
- Published
- January 1, 2020
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Fuji Food Products, Inc.
- Product
- Trader Joe's Tofu Spring Rolls 7oz, SKU 921510
- Reason
- RTE products potentially contaminated with Listeria monocytogenes.
- Published
- January 1, 2020
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Fuji Food Products, Inc.
- Product
- Trader Joe's Shrimp Spring Rolls 7oz, SKU 908795
- Reason
- RTE products potentially contaminated with Listeria monocytogenes.
- Published
- January 1, 2020
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Fuji Food Products, Inc.
- Product
- Trader Joe's 10oz Banh Mi Style Salad w/ Tofu, SKU 614719
- Reason
- RTE products potentially contaminated with Listeria monocytogenes.
- Published
- January 1, 2020
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Fuji Food Products, Inc.
- Product
- Trader Joe's 8.4oz Smoked Salmon Poke Bowl, SKU 603751
- Reason
- RTE products potentially contaminated with Listeria monocytogenes.
- Published
- January 1, 2020
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Fuji Food Products, Inc.
- Product
- Okami brand 8pc Salmon Philly Roll, SKU 28113
- Reason
- RTE products potentially contaminated with Listeria monocytogenes.
- Published
- January 1, 2020
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Fuji Food Products, Inc.
- Product
- Okami OK Tempura Shrimp Roll, 6pc w/ Sweet and Dynamite Sauc…
- Reason
- RTE products potentially contaminated with Listeria monocytogenes.
- Published
- January 1, 2020
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Fuji Food Products, Inc.
- Product
- Okami 8pc SEAFOOD COMBO 6 SURIMI 2 EBI SHRIMP, SKU 28262
- Reason
- RTE products potentially contaminated with Listeria monocytogenes.
- Published
- January 1, 2020
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Fuji Food Products, Inc.
- Product
- Okami brand 16pcs Sushi Platter, SKU 28201
- Reason
- RTE products potentially contaminated with Listeria monocytogenes.
- Published
- January 1, 2020
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Fuji Food Products, Inc.
- Product
- Okami brand 25pcs Sushi Platter, SKU 28200
- Reason
- RTE products potentially contaminated with Listeria monocytogenes.
- Published
- January 1, 2020
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Fuji Food Products, Inc.
- Product
- Okami brand 8pc Brown Rice Classic California Roll, SKU 2812…
- Reason
- RTE products potentially contaminated with Listeria monocytogenes.
- Published
- January 1, 2020
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Fuji Food Products, Inc.
- Product
- Okami brand 8pc Supreme Sampler, SKU 28112
- Reason
- RTE products potentially contaminated with Listeria monocytogenes.
- Published
- January 1, 2020
- Distribution
- Multiple states
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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