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 →
FDA Recall
Terminated
Historical 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
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Armada Nutrition
- Product
- PERFORMIX(TM) CREA-BEAD, MULTI-PHASE CREATINE, BLUE RAZZ ICE…
- Reason
- A raw material initially failed testing Staphylococcus aureus. A retest was conducted with passing results but an out of specification investigation was not properly conducted leaving concern that the finished product could contain the bacterium.
- Published
- May 3, 2017
- Distribution
- CO, NJ, England, South Africa,
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Armada Nutrition
- Product
- Muscle Meds(TM) PERFORMANCE TECHNOLOGIES, BIOENGINEERED BEEF…
- Reason
- A raw material initially failed testing Staphylococcus aureus. A retest was conducted with passing results but an out of specification investigation was not properly conducted leaving concern that the finished product could contain the bacterium.
- Published
- May 3, 2017
- Distribution
- CO, NJ, England, South Africa,
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Armada Nutrition
- Product
- USN B4 -BOMB EXTREME PRE-WORKOUT, LIME LEMONADE FLAVOUR, 300…
- Reason
- A raw material initially failed testing Staphylococcus aureus. A retest was conducted with passing results but an out of specification investigation was not properly conducted leaving concern that the finished product could contain the bacterium.
- Published
- May 3, 2017
- Distribution
- CO, NJ, England, South Africa,
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Armada Nutrition
- Product
- PERFORMIX(TM) CREA-BEAD, MULTI-PHASE CREATINE, UNFLAVOURED,…
- Reason
- A raw material initially failed testing Staphylococcus aureus. A retest was conducted with passing results but an out of specification investigation was not properly conducted leaving concern that the finished product could contain the bacterium.
- Published
- May 3, 2017
- Distribution
- CO, NJ, England, South Africa,
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Armada Nutrition
- Product
- BULK PRODUCT: MYPROTEIN, MYPRE Europe Base, bulk powder used…
- Reason
- A raw material initially failed testing Staphylococcus aureus. A retest was conducted with passing results but an out of specification investigation was not properly conducted leaving concern that the finished product could contain the bacterium.
- Published
- May 3, 2017
- Distribution
- CO, NJ, England, South Africa,
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Armada Nutrition
- Product
- MYPROTEIN, MYPRE V2(TM) Net Wt. 17.6 Oz (1.1 lb) /500g, Blu…
- Reason
- A raw material initially failed testing Staphylococcus aureus. A retest was conducted with passing results but an out of specification investigation was not properly conducted leaving concern that the finished product could contain the bacterium.
- Published
- May 3, 2017
- Distribution
- CO, NJ, England, South Africa,
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Henry-Broch Co
- Product
- JAP001 Jalapeno Powder, 44 lbs., cardboard carton with inter…
- Reason
- Potential contamination of product with Salmonella.
- Published
- May 3, 2017
- Distribution
- NJ and TX
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
ConAgra Foods Inc
- Product
- Premium Hunt's Chili Kit, Total NET WT 44.8 OZ (2.80 LB) 1.2…
- Reason
- Potential Salmonella contamination of spice packet within chili kits.
- Published
- May 3, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Armada Nutrition
- Product
- MP MUSCLEPHARM, ASSAULT, ENERGY + STRENGTH, THE ATHLETES PRE…
- Reason
- A raw material initially failed testing Staphylococcus aureus. A retest was conducted with passing results but an out of specification investigation was not properly conducted leaving concern that the finished product could contain the bacterium.
- Published
- May 3, 2017
- Distribution
- CO, NJ, England, South Africa,
View recall →
FDA Recall
Terminated
Historical recordClass II
Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units and 1 mg triamcinolone acetonide, distributed in a) 15 grams (NDC 51672-1263-1), b) 30 grams (NDC 51672-1263-2) and c) 60 grams (NDC 51672-1263-3) tubes, Rx only, TARO label; Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1 -- Dist. by: Taro Pharmaceuticals U.S.A. Inc., Hawthorne, NY 10532
by Taro Pharmaceuticals U.S.A., Inc.
- Reason
- Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability
- Published
- April 26, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
CLENZIderm M.D. Acne Treatment System, kit has 3 bottles a) Therapeutic Lotion (benzoyl peroxide 5% Acne Treatment) 47mL bottle, b) Daily Care Foaming Cleanser (Salicylic Acid 2% Acne Treatment) 118 mL bottle, c) Salicylic Acid 2% Acne Treatment 148mL, Valeant Pharmaceuticals North America LLC Distributed by OMP, Inc Long Beach, CA 90806 Made in USA, Product SKU 301876103018, NDC 0187-6103-01
by Valeant Pharmaceuticals North America LLC
- Reason
- Discoloration.
- Published
- April 26, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
CLENZIderm M.D. Pore Therapy Salicylic Acid 2% Acne Treatment 5 fl. oz. (148 mL), Valeant Pharmaceuticals North America LLC Distributed by OMP, Inc Long Beach, CA 90806 Made in USA. Product SKU 301876102042, NDC 0187-6102-04
by Valeant Pharmaceuticals North America LLC
- Reason
- Discoloration.
- Published
- April 26, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Dawn Food Products Inc.
- Product
- SHEILA G'S EGGLESS BROWNIE BRITTLE MIX Item 02403038 50 lb…
- Reason
- Products may contain Salmonella. These products contain ingredients recalled by Valley Milk Products for potential Salmonella contamination.
- Published
- April 26, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Dawn Food Products Inc.
- Product
- R&H CHOCOLATE Speedy Creme Instant Pudding and Pie Filling…
- Reason
- Products may contain Salmonella. These products contain ingredients recalled by Valley Milk Products for potential Salmonella contamination.
- Published
- April 26, 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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