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 I
Aroma Imports Inc
- Product
- Nabelsi Thyme (also known on invoices as Zatar) 450g retail…
- Reason
- Elevated lead levels in product
- Published
- May 10, 2017
- Distribution
- Illinois, Michigan, Ohio, Virginia, and…
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
🇺🇸 United States
Terminated
Historical recordClass I
Killer Brownie Distributing LLC
- Product
- PEANUT BUTTER KB KILLER BROWNIE¿ 3x35 CT NET WT 36 lbs (16.3…
- Reason
- The firm was notified by a customer that they received product that was mislabeled due to undeclared peanuts.
- Published
- May 10, 2017
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Killer Brownie Distributing LLC
- Product
- ORIGINAL KB KILLER BROWNIE¿ 3x35 CT NET WT 36 LBS (16.33 kg)…
- Reason
- The firm was notified by a customer that they received product that was mislabeled due to undeclared peanuts.
- Published
- May 10, 2017
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Killer Brownie Distributing LLC
- Product
- NOT-A-NUTTER KB KILLER BROWNIE¿ 3x35 CT NET WT 36 LBS (16.33…
- Reason
- The firm was notified by a customer that they received product that was mislabeled due to undeclared peanuts.
- Published
- May 10, 2017
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Killer Brownie Distributing LLC
- Product
- GERMAN CHOCOLATE KB KILLER BROWNIE¿ 3x35 CT NET WT 36 LBS (1…
- Reason
- The firm was notified by a customer that they received product that was mislabeled due to undeclared peanuts.
- Published
- May 10, 2017
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Ardent Mills Llc Usa
- Product
- Safeguard Flour product code 5122286 packaged in 50 lb bags
- Reason
- Product potentially contaminated with Salmonella
- Published
- May 10, 2017
- Distribution
- Product distributed to manufacturers in…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Arro Corporation
- Product
- 10.0 Grams Chili Spice Blend in packets
- Reason
- Possible contamination of chili seasoning mix with Salmonella.
- Published
- May 10, 2017
- Distribution
- OH
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 →
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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