FDA Recall
Terminated
Historical recordClass I
JIANFEIJINDAN Activity Girl Capsules, 400 mg, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL
by MyNicNaxs, Inc.
- Reason
- Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared ingredient: N-di-desmethylsibutramine, an analog of sibutramine
- Published
- June 18, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
REDUCE WEIGHT FRUTA PLANTA Capsules, 400 mg, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC., Deltona, FL
by MyNicNaxs, Inc.
- Reason
- Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: Phenolphthalein.
- Published
- June 18, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Bella Vi AMP'D UP Advanced Weight Loss Dietary Supplement capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ
by Pure Edge Nutrition
- Reason
- Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
- Published
- June 18, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Bella Vi INSANE AMP'D Dietary Supplement capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ
by Pure Edge Nutrition
- Reason
- Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
- Published
- June 18, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Bella Vi eXtreme ACCELERATOR Dietary Supplement Capsules, 30 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ
by Pure Edge Nutrition
- Reason
- Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
- Published
- June 18, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Bella Vi BTrim ULTIMATE BOOST Dietary Supplement capsules, 30 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ
by Pure Edge Nutrition
- Reason
- Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
- Published
- June 18, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Bella Vi BTrim MAX Dietary Supplement capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ
by Pure Edge Nutrition
- Reason
- Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
- Published
- June 18, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Bella Vi INSANE Bee Pollen Dietary Supplement Capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ
by Pure Edge Nutrition
- Reason
- Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
- Published
- June 18, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
vitaliKOR Ready When You Are, Fast Acting Formula Dietary Supplement capsules, 40 count bottle, Distributed by Vitality Research Labs, LLC, Las Vegas, NV 89148.
by Vitality Research Labs LLC
- Reason
- Marketed Without an Approved NDA/ANDA: FDA sampling found undeclared vardenafil and tadalafil in vitaliKOR capsules
- Published
- June 18, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Venlafaxine HCl Extended-Release Capsules, 150 mg, 90-count Unit of Use bottles, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-0182-2, UPC 3 59762-0182-2 9.
by Greenstone Llc
- Reason
- Presence of Foreign Tablets/Capsules: report of a foreign capsule with markings (TKN 250) and identified as a Tikosyn (dofetilide) capsule was found in a bottle of Effexor XR (venlafaxine HCl) 150 mg capsules that was packaged in the same packaging campaign as the recalled lot
- Published
- June 18, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 15% Povidone-iodine (USP) Surgical Hand Scrub; CareFusion, Vernon Hills, IL 60061 USA, NDC 57613-013-15.
by Carefusion 2200 Inc
- Reason
- Subpotent Drug: CareFusion is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner. The available iodine in the product is less than as stated on the product label.
- Published
- June 11, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 9% Povidone-iodine (USP) Surgical Hand Scrub; CareFusion, Vernon Hills, IL 60061 USA, NDC 57613-003-18
by Carefusion 2200 Inc
- Reason
- Subpotent Drug: CareFusion is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner. The available iodine in the product is less than as stated on the product label.
- Published
- June 11, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Marcaine (bupivacaine HCl) injection, USP, 0.25%, Preservative-Free, 10 mL (25 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USP, NDC 0409-1559-10.
by Hospira Inc.
- Reason
- Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.
- Published
- June 11, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
LOSARTAN POTASSIUM Tablets, USP, 50 mg, 30 count bottles, Rx only, Manufactured by Arrow Pharm (Malta) Ltd., Bizebbugia, Malta, Packaged by GSMS, Inc. Camarillo, CA --- NDC 60429-317-30
by Golden State Medical Supply Inc.
- Reason
- Presence of Foreign Substance; some bottles may contain debris that was swept up during cleaning
- Published
- June 11, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
GREENSTONE BRAND fluconazole for Oral Suspension, ORANGE FLAVORED, 40 mg/mL, when reconstituted, Rx only, Distributed by Greenstone LLC Peapack, NJ 07977. MADE IN INDIA. NDC 59762-5030-1
by Pfizer Inc.
- Reason
- Defective Container: Tamper evident ring failures discovered on some bottles.
- Published
- June 11, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100-count bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Water view Blvd., Parsippany, NJ 07054, USA. NDC: 64679-736-02.
by Wockhardt Usa Inc.
- Reason
- Failed Dissolution Specifications: Failure of dissolution test observed at three month time point.
- Published
- June 4, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
PediaCare brand DAY & NIGHT Value Pack DAYTIME MULTI-SYMPTOM Cold (dextromethorphan HBr 5 mg and Phenylephrine HCl 2.5 mg) and NIGHTTIME MULTI-SYMPTOM Cold (diphenhydramine HCl 6.25 mg and phenylephrine HCl 2.5 mg), 4 FL oz (118 mL) bottles, one each of DAYTIME MULTI-SYMPTOM Cold, Distributed by Medtech Products, Inc., Tarrytown, NY --- UPC 814832013523
by Prestige Brands Holdings
- Reason
- Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution
- Published
- June 4, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
PediaCare brand NIGHTTIME MULTI-SYMPTOM Cold, (diphenhydramine HCl 6.25 mg and phenylephrine HCl 2.5 mg), 4 FL OZ (118 mL), Distributed by Medtech Products, Inc., Tarrytown,NY ---- UPC 814832013544
by Prestige Brands Holdings
- Reason
- Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution
- Published
- June 4, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Cefpodoxime Proxetil Tablets, USP, 200 mg, 20 Tablet Bottles, Rx Only. Manufactured in Austria by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540. NDC 0781-5439-20.
by Sandoz, Inc
- Reason
- Presence of Foreign Substance: Presence of stainless steel particles.
- Published
- June 4, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Red Yeast Rice High Potency Dietary Supplement, 600 mg, packaged in a) 120-count VegeCaps per bottle (UPC 8 01650 02205 9) and b) 500-count VegeCaps per bottle (UPC 8 01650 02206 6), Manufactured by: Back to Health, Eugene, Oregon 97402.
by Independent Nutrition Center, Inc.
- Reason
- Marketed Without An Approved NDA/ANDA: Product is being recalled due to excessive levels of lovastatin. Lovastatin is an FDA approved drug making this dietary supplement an unapproved new drug.
- Published
- May 28, 2014
- 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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