FDA Recall
Ongoing
Historical recordClass II
Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC: 16729-440-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA.
by ACCORD HEALTHCARE, INC.
- Reason
- CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
- Published
- November 6, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30.
by Dr. Reddy's Laboratories, Inc.
- Reason
- CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
- Published
- November 6, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30.
by Dr. Reddy's Laboratories, Inc.
- Reason
- CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
- Published
- November 6, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-367-30.
by Dr. Reddy's Laboratories, Inc.
- Reason
- CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
- Published
- November 6, 2024
- Distribution
- Nationwide
View recall →
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 →
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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