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CriticalFDA
Jeni's Splendid Ice Creams Llc
Backyard Mint Ice Cream Bucket, 302, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Backyard M...
Dairy·61,267 affected·Apr 22, 2015
CriticalFDA
Jeni's Splendid Ice Creams Llc
Red Currant Cloverton Bucket, 377, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Red Curran...
Frozen Food·61,267 affected·Apr 22, 2015
CriticalFDA
Jeni's Splendid Ice Creams Llc
Riesling Poached Pear Sorbet Bucket, 321, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Riesl...
Frozen Food·61,267 affected·Apr 22, 2015
CriticalFDA
Jeni's Splendid Ice Creams Llc
Wintermint Sandwich Case, 506, Jeni's Splendid Ice Creams, LLC, 6oz sandwich, paper box, 14 boxes per case, frozen.
Frozen Food·236,267 affected·Apr 22, 2015
CriticalFDA
Jeni's Splendid Ice Creams Llc
Salty Vanilla Custard Bucket, 336, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Salty Vanill...
Frozen Food·61,267 affected·Apr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Famotodine Tablets, USP, 20 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-936-01), B) 100 Count Bottles(NDC: 64679-936-02), an...
Oral Drugs·69,008 affected·Apr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Famotodine Tablets, USP, 20 mg Tablets, For Repacking Only, Packaged in 6500 Count Drums, Over the Counter. Manufactured by: Wockhardt L...
Oral Drugs·539 affected·Apr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Clarithromycin Tablets, USP, 500 mg Tablets, 60 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by...
Oral Drugs·59,729 affected·Apr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Famotodine Tablets, USP, 40 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-937-01), B) 100 Count Bottles (NDC: 64679-937-02), a...
Oral Drugs·70,428 affected·Apr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Metoprolol Succinate Extended-Release Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0735-02), B) 500 Count Bo...
Oral Drugs·136,839 affected·Apr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Zolpidem Tartrate Tablets, 10 mg Tablets, CIV, Packaged in A) 100 Count Bottles (NDC: 64679-715-01) and B) 500 Count Bottles (NDC: 64679...
Injectable Drugs·36,213 affected·Apr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Lisinopril Tablets USP, 40 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-942-01), B) 500 Count Bottles (NDC: 64679-942-05), an...
Oral Drugs·174,571 affected·Apr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Amlodipine Besylate Tablets, 10 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-423-01) and B) 1000 Count Bottles (NDC: 64679-4...
Oral Drugs·152,164 affected·Apr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Lisinopril Tablets USP, 20 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-941-01), B) 500 Count Bottles (NDC: 64679-941-05), a...
Oral Drugs·121,608 affected·Apr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Amlodipine Besylate Tablets, 2.5 mg Tablets, Packaged in 90 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Di...
Oral Drugs·124,034 affected·Apr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Azithromycin Tablets, USP, 500 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0964-01) and B) 3 x 3 Tablet Card Cartons (NDC: 64...
Oral Drugs·112,120 affected·Apr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Extended Phenytoin Sodium Capsules, USP, 100 mg Capsules, Packaged as A) 100 Count Bottles (NDC: 64679-720-01) and B) 1000 Count Bottles ...
Oral Drugs·53,894 affected·Apr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Tamsulosin Hydrochloride Capsules, USP*, 0.4 mg Capsules, Packaged in A) 100 Count Bottles (NDC: 64679-516-02) and B) 500 Count Bottles (...
Oral Drugs·407,958 affected·Apr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Lamotrigine Extended-Release Tablets, 25 mg Tablets, 30 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distri...
Oral Drugs·5,910 affected·Apr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Azithromycin Tablets, USP, 250 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0961-01), B) 3,500 Count Pouches (NDC: 64679-961-0...
Oral Drugs·280,520 affected·Apr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Lisinopril Tablets USP, 2.5 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-927-01) and B) 500 Count Bottles (NDC: 64679-927-05)...
Oral Drugs·149,924 affected·Apr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Metoprolol Succinate Extended-Release Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0734-02), B) 500 Count Bo...
Oral Drugs·132,409 affected·Apr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Metoprolol Succinate Extended-Release Tablets, USP, 200 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0737-02) and B) 500 Coun...
Oral Drugs·33,422 affected·Apr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Captopril Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0903-01) and B) 1000 Count Bottles (NDC: 64679-0903-0...
Oral Drugs·162,743 affected·Apr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Zonisamide Capsules, 50 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distribu...
Oral Drugs·84,542 affected·Apr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, For Repackaging Only, Packaged in 4500 Count Pouches, Over the Counter. Manuf...
Oral Drugs·848 affected·Apr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Azithromycin Tablets, USP, 600 mg Tablets, Packaged in 30 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Dist...
Oral Drugs·7,584 affected·Apr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Lisinopril Tablets USP, 5 mg Tablets,Packaged in A) 100 Count Bottles (NDC: 64679-928-01), B) 500 Count Bottles (NDC: 64679-928-05), and ...
Oral Drugs·128,594 affected·Apr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, Packaged in 30 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mu...
Oral Drugs·16,276 affected·Apr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Zolpidem Tartrate Tablets, 5 mg Tablets, CIV, Packaged in 100 Tablet Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India...
Injectable Drugs·37,791 affected·Apr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Captopril Tablets, USP, 100 mg Tablets, Packaged in 100 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distri...
Oral Drugs·68,969 affected·Apr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Lansoprazole Delayed-Release Capsules, USP, 30 mg Capsules, Packaged in A) 30 Count Bottles (NDC: 64679-0670-01), B) 90 Count Bottles (ND...
Oral Drugs·178,832 affected·Apr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Zonisamide Capsules, 25 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distribu...
Oral Drugs·68,066 affected·Apr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Amlodipine Besylate Tablets, 5 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-422-01) and B) 1000 Count Bottles (NDC: 64679-422-...
Oral Drugs·146,959 affected·Apr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Zonisamide Capsules, 100 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distrib...
Oral Drugs·491,360 affected·Apr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Captopril Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0904-01) and B) 1000 Count Bottles (NDC: 64679-0904-0...
Oral Drugs·216,329 affected·Apr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Metoprolol Succinate Extended-Release Tablets, USP, 100 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0736-02), B) 500 Count B...
Oral Drugs·77,967 affected·Apr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Lisinopril Tablets USP, 30 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-953-01) and B) 500 Count Bottles (NDC: 64679-953-05...
Oral Drugs·63,203 affected·Apr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Famotodine Tablets, USP, 10 mg Tablets, For Repacking Only, Packaged in 50,000 Count Drums, Over the Counter. Manufactured by: Wockhardt...
Oral Drugs·1,002 affected·Apr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Lisinopril Tablets USP, 10 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-929-01), B) 500 Count Bottles (NDC: 64679-929-05), an...
Oral Drugs·133,920 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
D&C/Cysto Pack, Kit number PSS3257, PSS3257(A, and PSS3257(B convenience custom kits used for general surgery in hospital operating room
Medical Devices·615 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Shoulder Arthroscopy Pack, Kit number 002648-15, 002648-16, AMS2496, AMS2496(A, AMS2609, PSS2209(A, and PSS2209(B. convenience custom ki...
Medical Devices·1,124 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Cardiac Cath Pack, kit number AMS2707 convenience custom kits used for general surgery in hospital operating room
Cardiac Devices·138 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
C-Birth Pack, Kit part number AMS2037 and AMS2037(A convenience custom kits used for general surgery in hospital operating room
Medical Devices·48 affected·Apr 22, 2015
High RiskFDA
Lifeline Systems, Incorporated
Philips GoSafe Communicator 7000L Personal emergency response system.
Medical Devices·3,189 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Open Procedure Pack II, Kit number RMS1740(A convenience custom kits used for general surgery in hospital operating room
Medical Devices·145 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Minor Arthroscopy Pack, Kit number 002649-14 and 002649-15 convenience custom kits used for general surgery in hospital operating room
Medical Devices·356 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Spine Pack, Kit number AMS3753 and AMS3783(A convenience custom kits used for general surgery in hospital operating room
Medical Devices·86 affected·Apr 22, 2015