FDA Recall
Terminated
Historical recordClass II
Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count blister card, Rx only, MFG: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1203-03
by RemedyRePack Inc.
- Reason
- CGMP Deviations: Out of specification for dissolution
- Published
- July 24, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
STELLALIFE ADVANCED FORMULA Peppermint, VEGA Oral Care, Rinse, 16 fl oz (473 ml), Distributed by: StellaLife, 2875 NE 191 Street, Suite 500, Aventura, FL 33180, NDC 69685-143-16
by Homeocare Laboratories, Inc.
- Reason
- Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism
- Published
- July 24, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
STELLALIFE VEGA Oral Care, Spray, Unflavored, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, 22875 NE 191 Street, Suite 500, Aventura, FL 33180, NDC 69685-121-01
by Homeocare Laboratories, Inc.
- Reason
- Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms
- Published
- July 24, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Set, 2500mL (Approx. 50 mL excess), Single Dose Container Sterile and Non-Pyrogenic, For Intraperitoneal Administration Only, Fresenius Medical Care NA Waltham, MA 02451, 1-800-323-5188 NDC 49230-212-94
by Fresenius Medical Care Holdings, Inc.
- Reason
- This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
- Published
- July 24, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430. NDC 68462-357-05
by Glenmark Pharmaceuticals Inc., USA
- Reason
- CGMP Deviations
- Published
- July 24, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430. NDC 68462-357-01
by Glenmark Pharmaceuticals Inc., USA
- Reason
- CGMP Deviations
- Published
- July 24, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430. NDC 68462-357-05
by Glenmark Pharmaceuticals Inc., USA
- Reason
- Failed Dissolution Specifications
- Published
- July 24, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430. NDC 68462-357-01
by Glenmark Pharmaceuticals Inc., USA
- Reason
- Failed Dissolution Specifications
- Published
- July 24, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Cardura XL (doxazosin) extended release tablets 8mg, 30-count bottles, Rx Only Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2080-10
by Viatris Inc
- Reason
- Failed Impurities/Degradation Specifications
- Published
- July 24, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Cardura XL (doxazosin) extended release tablets 4mg, 30-count bottles, Rx Only, Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2040-10
by Viatris Inc
- Reason
- Failed Impurities/Degradation Specifications
- Published
- July 24, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, Manufactured in Canada By: Patheon, Inc., Mississauga, ON, Canada L5N 7K9, Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0997-02.
by Teva Pharmaceuticals USA, Inc
- Reason
- Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.
- Published
- July 24, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Oatmeal Daily Moisturizing Body Lotion (1.3% Dimethicone), 8 fl oz (236mL), packaged in an HDPE bottle 12 bottles per case, Manufactured By:/Fabrique Par: , Brands International Corp., Newmarket, ON, L3X 2S2, Made in Canada.
by Brands International Corporation
- Reason
- Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination
- Published
- July 24, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules per bottle, Manufactured by: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, Dehradun - 248-197, Uttarakhand, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-233-88.
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Failed Dissolution Specifications
- Published
- July 24, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Snapchill, LLC
- Product
- Tea + Honey Canned Beverage packaged under the following bra…
- Reason
- Potential under-processing.
- Published
- July 24, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Snapchill, LLC
- Product
- Tea Canned Beverage packaged under the following brands and…
- Reason
- Potential under-processing.
- Published
- July 24, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Snapchill, LLC
- Product
- Coffee + Lemonade Concentrate + Vanilla Syrup Canned Beverag…
- Reason
- Potential under-processing.
- Published
- July 24, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Snapchill, LLC
- Product
- Coffee + Oat Milk + Vanilla Syrup Canned Beverage packaged u…
- Reason
- Potential under-processing.
- Published
- July 24, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Snapchill, LLC
- Product
- Coffee + Oat Milk + Maple Syrup Canned Beverage packaged und…
- Reason
- Potential under-processing.
- Published
- July 24, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Snapchill, LLC
- Product
- Coffee + Oat Milk Canned Beverage packaged under the followi…
- Reason
- Potential under-processing.
- Published
- July 24, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Snapchill, LLC
- Product
- Coffee + Non-Dairy Creamer + Agave Nectar Canned Beverage pa…
- Reason
- Potential under-processing.
- Published
- July 24, 2024
- 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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