FDA Recall
Terminated
Historical recordClass II
HYDROXYPROG CAPROATE 250MG/ML OIL INJ, Rx only, Red Mountain Compounding Rx
by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- Published
- November 3, 2021
- Distribution
- 494 patients/consumers received prescrip…
View recall →
FDA Recall
Terminated
Historical recordClass II
GLUTATHIONE 200MG/ML MDV, Rx only, Red Mountain Compounding Rx
by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- Published
- November 3, 2021
- Distribution
- 494 patients/consumers received prescrip…
View recall →
FDA Recall
Terminated
Historical recordClass II
ESTRADIOL VALERATE 5MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- Published
- November 3, 2021
- Distribution
- 494 patients/consumers received prescrip…
View recall →
FDA Recall
Terminated
Historical recordClass II
DEXPANTHENOL 250MG/ML INJ SOLN, Rx only, Red Mountain Compounding Rx
by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- Published
- November 3, 2021
- Distribution
- 494 patients/consumers received prescrip…
View recall →
FDA Recall
Terminated
Historical recordClass II
CYCLOSPORINE 2% MCT OIL SUSP, Rx only, Red Mountain Compounding Rx
by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- Published
- November 3, 2021
- Distribution
- 494 patients/consumers received prescrip…
View recall →
FDA Recall
Terminated
Historical recordClass II
CYCLOSPORIN 0.2% OIL OPTH SUSP, Rx only, Red Mountain Compounding Rx
by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- Published
- November 3, 2021
- Distribution
- 494 patients/consumers received prescrip…
View recall →
FDA Recall
Terminated
Historical recordClass II
ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, Rx only, Red Mountain Compounding Rx
by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- Published
- November 3, 2021
- Distribution
- 494 patients/consumers received prescrip…
View recall →
FDA Recall
Terminated
Historical recordClass II
ASCORBIC ACID (NON-CORN) 500MG/ML SOLN (PF), Rx only, Red Mountain Compounding Rx
by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- Published
- November 3, 2021
- Distribution
- 494 patients/consumers received prescrip…
View recall →
FDA Recall
Terminated
Historical recordClass II
ASCORBIC ACID (NON-CORN) 500MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx
by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- Published
- November 3, 2021
- Distribution
- 494 patients/consumers received prescrip…
View recall →
FDA Recall
Terminated
Historical recordClass II
LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx
by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- Published
- November 3, 2021
- Distribution
- 494 patients/consumers received prescrip…
View recall →
FDA Recall
Terminated
Historical recordClass II
Magnesium Chloride, 200 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx
by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- Published
- November 3, 2021
- Distribution
- 494 patients/consumers received prescrip…
View recall →
FDA Recall
Terminated
Historical recordClass II
Calcium Chloride, 100 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx
by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- Published
- November 3, 2021
- Distribution
- 494 patients/consumers received prescrip…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Nestle Usa Inc
- Product
- Nature's Heart Pineapple Chili Cashew Glazed Mix 1.5oz poly…
- Reason
- Undeclared Allergen - Peanuts
- Published
- November 3, 2021
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Nestle Usa Inc
- Product
- Nature's Heart Toasted Coconut Chips 1.5oz poly film pouche…
- Reason
- Undeclared Allergen - Peanuts
- Published
- November 3, 2021
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Schlotterbeck & Foss LLC
- Product
- Simply Nature Organic Poppy Seed Dressing
- Reason
- product may not be acidified
- Published
- November 3, 2021
- Distribution
- Alabama, Arizona, California, Connecticu…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Nestle Usa Inc
- Product
- Nature's Heart Mango Turmeric Cashew Glazed Mix 1.5oz poly…
- Reason
- Undeclared Allergen - Peanuts
- Published
- November 3, 2021
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Nestle Usa Inc
- Product
- Nature's Heart Superfood Trail Mix 1.5oz poly film pouches…
- Reason
- Undeclared Allergen - Peanuts
- Published
- November 3, 2021
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
SIMPLE MILLS
- Product
- Almond Flour Crackers fine ground sea salt packaged in a whi…
- Reason
- Undeclared Milk Allergen.
- Published
- November 3, 2021
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
Imipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 UNited States. Manufactured by: Lupin Limited, Pithampur, (M.P.) 454 775 India NDC# 68180-316-06
by Lupin Pharmaceuticals Inc.
- Reason
- Out of specification result observed in a dissolution test at the 9-month long term stability time point.
- Published
- October 27, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole magnesium), 24 Hour, 14-count capsules per bottle within a carton, Distributed by Cardinal Health, Dublin, OH 43017, NDC 70000-0232-1
by Dr. Reddy's Laboratories, Inc.
- Reason
- CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
- Published
- October 27, 2021
- 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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