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
Donepezil HCl tablets, 10mg, packaged in 10x10 blister packs per carton (100 Unit Dose) container, Rx only, Manufactured by Sandoz, Inc., 506 Carnegie Center, Suite 400, Princeton, NJ 08805, Distributed by: McKesson Packaging Services, 7101 Weddington Rd, Concord, NC 28027, NDC 63739-678-10
by Mckesson Packaging Services
- Reason
- Supotent: Out of Specification result for assay test during routine stability testing.
- Published
- May 3, 2017
- Distribution
- CO, LA and OH.
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 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 →
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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