FDA Recall
TerminatedTerminated: August 11, 2022Historical recordClass III
Cleocin Phosphate, clindamycin injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017, NDC 0009-3124-01
by Pfizer Inc.
- Reason
- Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
- Published
- April 10, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: August 11, 2022Historical recordClass III
Cleocin Phosphate (clindamycin injection), USP, 300 mg/ 2 mL (150 mg/mL), 2 mL-vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017, NDC 0009-6582-02
by Pfizer Inc.
- Reason
- Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
- Published
- April 10, 2019
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: April 6, 2020Historical recordClass II
Better Made Snack Foods Inc.
- Product
- Better Made Snack Foods Family Size $3.99 Original Potato Ch…
- Reason
- Undeclared milk
- Published
- April 10, 2019
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: June 28, 2019Historical recordClass II
Fungi Perfecti LLC
- Product
- Host Defense MycoBotanicals Blood Sugar, dietary supplement,…
- Reason
- Host Defense MycoBotanicals Blood Sugar, 60 ct. bottles, is recalled due to undeclared wheat.
- Published
- April 10, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: February 27, 2023Historical recordClass I
Blue Fusion Capsules, 1- count blister pack, Distributed by: DNS Distribution 5225 Canyon Crest Dr. Ste 71-640, Riverside, CA 92507, UPC 7 48252 66460 0
by Ata International Inc
- Reason
- Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared ingredients: Sildenafil, Tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil, scutellarin, and daidzein.
- Published
- April 3, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: August 11, 2022Historical recordClass II
Express Gel Hand Sanitizer (Ethyl Alcohol 70%), 37 mL (1.25 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 47593-502-49
by Ecolab Inc
- Reason
- Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
- Published
- April 3, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: August 11, 2022Historical recordClass II
Quick-Care Foam Hand Sanitizer (Ethyl alcohol 62%), 45 mL (1.5 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 47593-491-85
by Ecolab Inc
- Reason
- Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
- Published
- April 3, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: August 11, 2022Historical recordClass II
Moisturizing Gel Hand Sanitizer (Ethyl Alcohol 62%), 118 mL (4 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 47593-489-33
by Ecolab Inc
- Reason
- Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
- Published
- April 3, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: August 11, 2022Historical recordClass II
Advanced Gel Hand Sanitizer (Ethyl alcohol 62%), packaged in a) 37 mL (1.25 fl oz) bottles (NDC 47593-488-49) and b) 540 mL (18 fl oz) bottles (NDC 47593-488-31) Ecolab, 370 Wabasha Street N, St. Paul, MN 55102.
by Ecolab Inc
- Reason
- Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
- Published
- April 3, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: August 11, 2022Historical recordClass II
Gel Hand Sanitizer (Ethyl Alcohol 70%), packaged in a) 37 mL (1.25 fl oz) bottles (NDC 47593-487-49), b) 118 mL (4 fl oz) bottles (NDC 47593-487-33), and c) 540 mL (18 fl oz) bottles (NDC47593-487-31) Ecolab, 370 Wabasha Street N, St. Paul, MN 55102.
by Ecolab Inc
- Reason
- Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
- Published
- April 3, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 6, 2020Historical recordClass III
Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408, NDC 50742-308-05.
by Ingenus Pharmaceuticals Llc
- Reason
- Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.
- Published
- April 3, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: July 1, 2020Historical recordClass II
Fayosim (levonorgestrel and ethinyl estradiol) tablets USP, (0.15 mg/0.02 mg, 0.15 mg/0.025 mg, 0.15 mg/0.03 mg) and ethinyl estradiol tablets USP, (0.01 mg), packaged in 1 Extended-Cycle Wallet of 91 Tablets packed in a pouch(NDC 68180-860-11); one pouch per carton (NDC 68180-860-12), Rx only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454775, INDIA.
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications: Out-of-specification results observed in related substance test (Any Other Individual Impurity and Total impurities) in Ethinyl Estradiol Tablets USP 0.01mg at 12 month long term stability study.
- Published
- April 3, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 15, 2019Historical recordClass II
Nature's Touch Frozen Foods, LLC
- Product
- O Organics Organic Whole Strawberries; NET WT. 48 oz. (3 lb…
- Reason
- FDA Testing for Frozen Berry Assignment found Norovirus in frozen strawberries from Turkey.
- Published
- April 3, 2019
- Distribution
- MD, IL, MA, UT, CA, WA.
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 20, 2020Historical recordClass II
Hometown Food Company
- Product
- Pillsbury Unbleached All Purpose Flour Enriched 5Lb paper…
- Reason
- Product may be contaminated with Salmonella
- Published
- April 3, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: August 21, 2019Historical recordClass II
Jacques Torres Manufacturing , llc.
- Product
- Jacques Big Daddy Dark Chocolate Bar. The product comes in…
- Reason
- Product contains undeclared milk.
- Published
- April 3, 2019
- Distribution
- California, Connecticut, New York, Maryl…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: June 27, 2019Historical recordClass I
Utz Quality Food Inc
- Product
- Bachman Original Twist Pretzels,10 oz.Bag (flexible film) UP…
- Reason
- Utz Quality Food, LLC is initiating a recall of Bachman Original Twist Pretzels,10 oz.Bag (flexible film) Net Wt.: 10 oz., UPC: 0 77817 10580 8 , because of Undeclared milk allergen. Butter Twist pretzels mistakenly packaged into regular Pretzel Twist bags.
- Published
- April 3, 2019
- Distribution
- The product was distributed to the follo…
View recall →
FDA Recall
TerminatedTerminated: March 4, 2021Historical recordClass II
Etomidate Injection, USP 20 mg/10mL (2mg/mL) 10 mL Single-Dose Vial, Rx only, Manufactured for: Heritage Pharmaceuticals Inc. Made in India, NDC 23155-160-31
by Heritage Pharmaceuticals, Inc.
- Reason
- Subpotent Drug.
- Published
- March 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045. NDC 68645-578-54
by Legacy Pharmaceutical Packaging LLC
- Reason
- CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
- Published
- March 27, 2019
- Distribution
- Wal-Mart distribution centers in AR, CA,…
View recall →
FDA Recall
TerminatedTerminated: December 7, 2020Historical recordClass II
Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-514-15
by AVKARE Inc.
- Reason
- CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
- Published
- March 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 7, 2020Historical recordClass II
Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-513-15
by AVKARE Inc.
- Reason
- CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
- Published
- March 27, 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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