FDA Recall
Terminated
Historical recordClass II
Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg / 40 mg per 5 mL , Grape Flavor, Rx Only, 16 fl oz. (473 mL), HI-TECH PHARMACAL CO., INIC, Amityville, NY 11701, NDC 50383-824-16
by Akorn Inc
- Reason
- Failed Dissolution Specifications
- Published
- May 10, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Zinc Oxide Paste 25%, 500 g, For Prescription Compounding, Fagron Inc.2400 Pilot Knob Rd, St. Paul, MN 55120m NDC 51522-0694-5.
by Fagron, Inc
- Reason
- Labeling: Error on Declared Strength: Error is due to an incorrect value in the Drug Facts Panel. The correct strength is displayed on the primary container.
- Published
- May 10, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Allergy Relief Diphenhydramine HCl 25 mg, Antihistamine, Dye-Free, 24 Softgels, distributed under the following labels: (a) TopCare Allergy Relief, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, NDC 36800-483-24, UPC 0-36800-39134-5; (b) Rexall Since 1903 Allergy Relief, PACKAGED FOR DOLGENCORP, LLC, 100 MISSION RIDGE GOODLETTSVILLE, TN 37072, UPC 3-59726-72025-0; (c) HyVee health Allergy Relief, DISTRIBUTED BY HY-VEE, INC. 5820 WESTOWN PARKWAY, WEST DES MOINES, IA 50266, NDC 42507-483-24, UPC 0-75450-12369-2; (d) up & up allergy relief, Distributed by Target Corporation, Minneapolis, MN 55403, NDC 11673-720-24, UPC 3-59726-72025-0; (e) smart sense allergy softgels, Distributed by Kmart Corporation, Hoffman Estates, IL 60179, NDC 49738-483-24, UPC 8-83967-39839-3.
by P & L Development, LLC
- Reason
- Subpotent: This product is being recalled due to low out of specification assay results at the 9 month time point.
- Published
- May 10, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65162-0724-03), b) 90-count bottle (NDC 65162-0724-09), Rx Only, Manufactured by Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad INDIA 382220, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ 08807
by Amneal Pharmaceuticals LLC
- Reason
- Failed Dissolution Specifications
- Published
- May 10, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada, Distributed by Major Pharmaceuticals, Livonia, MI NDC 0904-6509-04
by The Harvard Drug Group
- Reason
- Superpotent Drug; out of specification results for assay (manufacturer)
- Published
- May 10, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
EpiPen Jr. 2-Pak (Epinephrine) Auto-Injectors 0.15 mg, Rx only, Manufactured for Mylan Specialty L.P., Morgantown WV 26505 by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company; NDC 49502-500-02 ---- ALSO LABELED OUTSIDE THE US AS: Epipen Auto-Injector Jr. 0.15 mg -Bright Stock labeled for multiple countries- manufactured for Mylan by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company.
by Meridian Medical Technologies a Pfizer Company
- Reason
- Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication
- Published
- May 10, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
EpiPen 2-Pak (Epinephrine) Auto-Injectors 0.3 mg, Rx only, Manufactured for Mylan Specialty L.P., Morgantown WV 26505 by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company; NDC 49502-500-02 ---- ALSO LABELED OUTSIDE THE US AS ---- Epipen Auto-Injector 0.3 mg -Bright Stock labeled for multiple countries- manufactured for Mylan by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company.
by Meridian Medical Technologies a Pfizer Company
- Reason
- Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication
- Published
- May 10, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fluconazole Tablets, USP, 200 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI 48150 USA, NDC 0904-6501-61
by The Harvard Drug Group
- Reason
- Failed Dissolution Specifications
- Published
- May 10, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI 48150 USA, NDC 0904-6500-61
by The Harvard Drug Group
- Reason
- Failed Dissolution Specifications
- Published
- May 10, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Threshold Enterprises Ltd
- Product
- Source Naturals Dietary Supplement Vitamin D-3; Bioactive…
- Reason
- Testing of Vitamin D-3 as a result of a consumer complaint found specific lots to have lower concentrations than product specifications of ingredient labeling.
- Published
- May 10, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Weaver Popcorn Co.
- Product
- Trail's End Chicago Cubs Sweet and Savory Collection Trai…
- Reason
- Product has the potential to be contaminated with Salmonella
- Published
- May 10, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phenylephrine 2.5%, Tropicamide 1%, 15 mL Multi-Dose Ophthalmic (spelled Opthalmic) Drops in a bottle, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1300, barcode 3 70285 13001 4.
by Isomeric Pharmacy Solution, LLC
- Reason
- Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- Published
- May 3, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Testosterone Cypionate 200 mg/mL, Testosterone Propionate 20 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1200, barcode 3 70285 12003 9.
by Isomeric Pharmacy Solution, LLC
- Reason
- Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- Published
- May 3, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol 50 mg/mL/ Choline 50 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1101, barcode 3 70285 11013 9.
by Isomeric Pharmacy Solution, LLC
- Reason
- Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- Published
- May 3, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Triamcinolone Diacetate 40 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1021, barcode 3 70285 10211 0.
by Isomeric Pharmacy Solution, LLC
- Reason
- Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- Published
- May 3, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Triamcinolone Acetonide 40 mg/mL, Lidocaine HCl 10 mg/mL , 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1020, barcode 3 70285 10201 1.
by Isomeric Pharmacy Solution, LLC
- Reason
- Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- Published
- May 3, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Methylprednisolone Acetate 80 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1011, barcode 3 70285 10111 3.
by Isomeric Pharmacy Solution, LLC
- Reason
- Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- Published
- May 3, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Methylprednisolone Acetate 40 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1010, barcode 3 70285 10101 4.
by Isomeric Pharmacy Solution, LLC
- Reason
- Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- Published
- May 3, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Pilocarpine Hydrochloride Ophthalmic Solution 4% , packaged in 15 mL bottles, Rx Only, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 Sandoz Princeton, NJ 08540, NDC 61314-206-15
by Novartis Pharmaceuticals Corp.
- Reason
- Failed Impurities/Degradation Specifications.
- Published
- May 3, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Isopto Carpine (pilocarpine hydrochloride opthalmic solution) 4%, packaged in 15 mL bottle, Rx only, Manufactured by: Alcon Laboratories, Inc. Fort Worth Texas 76134 USA NDC 0998-0206-15
by Novartis Pharmaceuticals Corp.
- Reason
- Failed Impurities/Degradation Specifications.
- Published
- May 3, 2017
- 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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