FDA Recall
Terminated
Historical recordClass II
Rifampin Capsules, USP, 300 mg, packaged in a) 30-count bottle (NDC 51407-323-30), b) 60-count bottle (NDC 51407-323-60), c) 100-count bottle (NDC 51407-323-01), Rx only, Manufactured by Patheon Pharmaceuticals Inc., OH, Packaged by GSMS, Incorporated, CA.
by Golden State Medical Supply Inc.
- Reason
- Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
- Published
- October 26, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Flunisolide Nasal Solution, USP 0.025%, 25 mL bottles, Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408; NDC 50742-317-25 UPC 3 50742 31725 7
by Ingenus Pharmaceuticals Llc
- Reason
- Out of specification for related substances (impurities).
- Published
- October 26, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
D. F. Stauffer Biscuit Co, Inc.
- Product
- White frosted animal cookies with multi-colored non-pareils…
- Reason
- Potential contamination with foreign material (metal).
- Published
- October 26, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Eden Foods, Inc
- Product
- Eden Organic Apple Juice in 32floz., 64floz., and 1.82L size…
- Reason
- culling not performed to remove rotted apples, excessive levels of patulin found in 1 lot
- Published
- October 19, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics Pharma LLC E. Windsor, NJ 08520, Made in India, NDC 55150-188-10
by AuroMedics Pharma LLC
- Reason
- Presence of Particulate Matter: Piece of metal found in a vial
- Published
- October 12, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial packaged in 5 x 2 mL Sterile Unit-Dose Vials per pouch, NDC 69097-168-48; 60 (12 x 5) x 2 mL Sterile Unit-Dose Vials per carton, NDC 69097-168-64, Rx Only, Manufactured by: Cipla Ltd., Indore SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059.
by CIPLA
- Reason
- Lack of Assurance of Sterility: environmental monitoring failure.
- Published
- October 12, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass III
Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-405-16
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
- Published
- October 12, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45
by ALMIRALL, LLC
- Reason
- Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
- Published
- October 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Rifampin Capsules, USP, 300 mg, a) 30-count bottle (NDC 61748-018-30), b) 60-count bottle (NDC 61748-018-60), c) 100-count bottle (NDC 61748-018-01), Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031.
by Akorn, Inc.
- Reason
- Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
- Published
- October 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031, NDC 61748-015-30
by Akorn, Inc.
- Reason
- Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
- Published
- October 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
ClomiPRAMINE Hydrochloride Capsules, USP 25mg, 100-count bottles, Rx only, LEADING PHARMA, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-167-01
by Leading Pharma, LLC
- Reason
- Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules
- Published
- October 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose Ampules per pouch, Sterile Suspension, Manufactured by: Cipla Ltd., India, Manufactured for Cipla USA Inc., Warren NJ, NDC# 69097-318-86.
by CIPLA
- Reason
- Lack of Assurance of Sterility
- Published
- October 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injection for IV Use, High Alert, This is a Compounded Product for Institutional or Office Use Only, Not for Resale, QuVa PHARMA 519 Route 173, Bloomsbury, NJ 08804, Total volume: 500 mL bag, NDC: 70092-1068-07.
by QuVa Pharma, Inc.
- Reason
- Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL).
- Published
- October 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton, Mfg by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, NDC # 0078-0246-15.
by Novartis Pharmaceuticals Corporation
- Reason
- CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
- Published
- October 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ampicillin for Injection, USP, 2 grams/vial NDC 67457-352-02, packaged in 10 x 2 g vials per carton NDC 67457-352-10, Rx only, Mylan Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103 U.S.A
by Viatris Inc
- Reason
- Presence of Particulate Matter: A complaint was received for the presence of a single strand of hair in one vial.
- Published
- October 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-735-90.
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Superpotent Drug: Out of specification for assay at the 12-month timepoint.
- Published
- October 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-734-90.
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Superpotent Drug: Out of specification for assay at the 12-month timepoint.
- Published
- October 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
World Variety Produce Inc dba Melissa's
- Product
- Dutch Red Potatoes with Dijon Mustard Sauce. NET WT. 1 LB 1…
- Reason
- Dutch Red Potatoes were packed with a Dijon Mustard Sauce packet that did not declare the allergen of egg.
- Published
- October 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Lamb Weston Sales
- Product
- Item SP204, Sprouts Organic Hash Browns Shredded Potatoes, 1…
- Reason
- Potential to be contaminated with Listeria monocytogenes.
- Published
- October 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Lamb Weston Sales
- Product
- Item GV020, Great Value Shredded Hash Browns, 4 lbs. bag, 6/…
- Reason
- Potential to be contaminated with Listeria monocytogenes.
- Published
- October 5, 2022
- 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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