FDA Recall
OngoingHistorical 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
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FDA Recall
TerminatedTerminated: August 4, 2017Historical 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
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FDA Recall
TerminatedTerminated: August 4, 2017Historical 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
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FDA Recall
🇺🇸 United States
TerminatedTerminated: May 3, 2017Historical 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
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FDA Recall
🇺🇸 United States
TerminatedTerminated: July 20, 2017Historical 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
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FDA Recall
🇺🇸 United States
TerminatedTerminated: December 2, 2021Historical recordClass I
Seafarers Inc.
- Product
- Pre-cooked, chilled, Fresh Claw Crabmeat, 1 lb, packaged in…
- Reason
- Products may be contaminated with Listeria monocytogenes.
- Published
- May 10, 2017
- Distribution
- Distributed to the following states: DE,…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: December 2, 2021Historical recordClass I
Seafarers Inc.
- Product
- Pre-cooked, chilled, Fresh Lump Crabmeat, 1 lb, packaged in…
- Reason
- Products may be contaminated with Listeria monocytogenes.
- Published
- May 10, 2017
- Distribution
- Distributed to the following states: DE,…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: December 2, 2021Historical recordClass I
Seafarers Inc.
- Product
- Precooked, chilled, Fresh Jumbo Lump Crabmeat, 1 lb, package…
- Reason
- Products may be contaminated with Listeria monocytogenes.
- Published
- May 10, 2017
- Distribution
- Distributed to the following states: DE,…
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FDA Recall
TerminatedTerminated: August 30, 2017Historical 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
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FDA Recall
TerminatedTerminated: August 30, 2017Historical 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
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FDA Recall
TerminatedTerminated: August 30, 2017Historical 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
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FDA Recall
TerminatedTerminated: August 30, 2017Historical 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
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FDA Recall
TerminatedTerminated: August 30, 2017Historical 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
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FDA Recall
TerminatedTerminated: August 30, 2017Historical 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
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FDA Recall
TerminatedTerminated: August 30, 2017Historical 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
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FDA Recall
TerminatedTerminated: February 5, 2020Historical 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
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FDA Recall
TerminatedTerminated: February 5, 2020Historical 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
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FDA Recall
TerminatedTerminated: May 8, 2019Historical recordClass II
hCG Body Shaper, Highly Purified Human Chorionic Gonadotrophin 5000 IU, Colloidal Silver B12, Stabilizers/Excipients, Not For Medical Use, Must Be Refrigerated, Distributed by HCG Body Shaper, St. Peters, MO
by Gary Wood
- Reason
- Marketed without an Approved NDA/ANDA; FDA analysis has found the product to be tainted with human chorionic gonadotropin, rendering it an unapproved drug
- Published
- May 3, 2017
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: July 6, 2017Historical recordClass II
McCain Foods USA
- Product
- Roundy's Southern Style Diced Hash Browns, frozen, net wt. 3…
- Reason
- Southern Style Hash Brown products are recalled because they are contaminated with extraneous golf ball material
- Published
- May 3, 2017
- Distribution
- distributed in District of Columbia, Del…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: February 22, 2018Historical recordClass I
Guggisberg Cheese Inc
- Product
- Thunder Jack Cheese sold under the following brand names: Am…
- Reason
- The firm was notified that the product may contain Listeria monocytogenes.
- Published
- May 3, 2017
- Distribution
- Product was shipped to the following sta…
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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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