FDA Recall
Ongoing
Historical recordClass II
OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxative, 16 FL OZ (473 mL) bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., Fairfield, NJ 07004, NDC 71399-0039-06.
by Akron Pharma, Inc.
- Reason
- CGMP Deviations
- Published
- October 30, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg,
by C & A Naturistics
- Reason
- Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.
- Published
- October 30, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-079-56
by Fresenius Kabi Compounding, LLC
- Reason
- cGMP violations
- Published
- October 30, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-060-58
by Fresenius Kabi Compounding, LLC
- Reason
- cGMP violations
- Published
- October 30, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-028-59
by Fresenius Kabi Compounding, LLC
- Reason
- cGMP violations
- Published
- October 30, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-027-58
by Fresenius Kabi Compounding, LLC
- Reason
- cGMP violations
- Published
- October 30, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-025-58
by Fresenius Kabi Compounding, LLC
- Reason
- cGMP violations
- Published
- October 30, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-014-58
by Fresenius Kabi Compounding, LLC
- Reason
- cGMP violations
- Published
- October 30, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-029-58
by Fresenius Kabi Compounding, LLC
- Reason
- cGMP violations
- Published
- October 30, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-010-58
by Fresenius Kabi Compounding, LLC
- Reason
- cGMP violations
- Published
- October 30, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-024-58
by Fresenius Kabi Compounding, LLC
- Reason
- cGMP violations
- Published
- October 30, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-002-58
by Fresenius Kabi Compounding, LLC
- Reason
- CGMP violations
- Published
- October 30, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Youngstown Grape Distributors, Inc.
- Product
- Farmers Juice Watermelon Hydration packaged in a 12 fl. oz.…
- Reason
- Incomplete pasteurization
- Published
- October 30, 2024
- Distribution
- CA, TX, WA, KY, NC, NY, IL, VA, AL, GA,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Youngstown Grape Distributors, Inc.
- Product
- Farmers Juice Carrot Digest packaged in a 12 fl. oz. bottle;…
- Reason
- Incomplete pasteurization
- Published
- October 30, 2024
- Distribution
- CA, TX, WA, KY, NC, NY, IL, VA, AL, GA,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Youngstown Grape Distributors, Inc.
- Product
- Farmers Juice Focus Greens packaged in a 12 fl. oz. bottle;…
- Reason
- Incomplete pasteurization
- Published
- October 30, 2024
- Distribution
- CA, TX, WA, KY, NC, NY, IL, VA, AL, GA,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Youngstown Grape Distributors, Inc.
- Product
- Happy Moose Juice Strawberry Field packaged in a plastic 12…
- Reason
- Incomplete pasteurization
- Published
- October 30, 2024
- Distribution
- CA, TX, WA, KY, NC, NY, IL, VA, AL, GA,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Youngstown Grape Distributors, Inc.
- Product
- Happy Moose Juice Tropical Roots packaged in a plastic 12 fl…
- Reason
- Incomplete pasteurization
- Published
- October 30, 2024
- Distribution
- CA, TX, WA, KY, NC, NY, IL, VA, AL, GA,…
View recall →
FDA Recall
Ongoing
Historical recordClass II
First Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients: mineral oil, petrolatum. NET Wt. 1 OZ (28.4 g) per tube, Distributed by: Rugby Laboratories, Indianapolis, IN 46268. Made in China. NDC: 0536-1271-80
by Zhejiang Jingwei Pharmaceutical Co., Ltd.
- Reason
- Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000.
- Published
- October 23, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, NDC # 69452-252-87.
by Bionpharma Inc.
- Reason
- Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
- Published
- October 23, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Only, Manufactured for: Accord Healthcare Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad 382 213, India. Mfg. Lic. No.: G/28/1336, NDC 16729-288-38
by ACCORD HEALTHCARE, INC.
- Reason
- Failed Impurities/Degradation Specifications.
- Published
- October 23, 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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