Class I - Dangerous
Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Class I - Dangerous
Subpotent
Ginseng Power 5000 capsule, 1- count per blister card, GS Natural Co, Los Angeles, CA 90010, UPC 0 40232 18144 3
NSNY Distributor
Class I - Dangerous
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil
DiBAR LABS Hand Sanitizer (ethyl alcohol 70%), 8 FL OZ. (236.5 mL), Distributed by S.E.N.D. LLC, Anthony, NM 88021, Imported by Dibar Labs, LLC, Sugar Land, TX 77479, Made in Mexico,77479, NDC 73009-0001-08 UPC 8 53090 00301 3.
DIBAR NUTRICIONAL S DE RL DE CV
Class I - Dangerous
Chemical Contamination: FDA analysis found 3 lots of DiBAR hand Sanitizer to be below the label claim for ethanol content and to contain methanol.
ProtectoRx (ethyl alcohol 70%), packaged in a) 2 FL OZ (59 mL), NDC 75408-002-01 and b) 16 FL OZ (473.2 mL), NDC 75408-002-02 bottles, Imported by: Dibar Labs, LLC., Sugar Land, TX 77479; Distributed by: PR Trading LLC, PO Box 19647, San Juan, PR 00910, Made in Mexico.
DIBAR NUTRICIONAL S DE RL DE CV
Class I - Dangerous
CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
ADVANCE HAND SANITIZER, (ethyl alcohol 70%), 16 FL OZ (473.2 mL), Imported by: Dibar Labs, LLC,.Sugar Land, TX 77479, Distributed by: Lifetime Health Services, Pharr, TX 78577, Made in Mexico, NDC; 79284-005-00. UPC 8 60004 06470 1
DIBAR NUTRICIONAL S DE RL DE CV
Class I - Dangerous
CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
Class I - Dangerous
CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
Premium OrgaZEN 7000 capsule, 1-count per blister card, distributed by: Nutra Vita Co, Santa Fe Springs, CA, Made in USA , UPC 0 40232 32555 7
NSNY Distributor
Class I - Dangerous
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil
Class I - Dangerous
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class I - Dangerous
Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
Class I - Dangerous
Presence of Foreign Substance: Foreign particles observed during routine stability testing.
Mephyton (Phytonadione) 5 mg tablets, 100-count tablets, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC, Bridgewater, NJ, 08807, USA, NDC 0187-1704-05.
Bausch Health Companies
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Class I - Dangerous
Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Class I - Dangerous
Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Phytonadione Tablets, 5 mg, 30-count ablets, Rx only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA, NDC 68682-170-30
Bausch Health Companies
Class I - Dangerous
Failed Impurities/Degradation Specifications
Ketamine HCl Injection Solution, 10 mg / 2 mL (5 mg/mL), Rx Only, Compounded by Prisma Health Outsourcing Facility 1071 Holland Rd. Suite 2 Simpsonville, SC 29681. NDC: 73463-0100-01
Prisma Health Outsourcing Facility
Class I - Dangerous
Labeling: Incorrect Exp. Date: Incorrect BUD.
Class I - Dangerous
Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.
Class I - Dangerous
Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ingredients Sibutramine and Fluoxetine
Atorvastatin Calcium Tablets, USP 10 mg, 500-count bottles, Rx Only, Dr. Reddy's Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, 500-090 India, NDC 55111-121-05.
Dr. Reddy's Laboratories
Class I - Dangerous
Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities