Class I - Dangerous
Low out of specification results for epinephrine assay.
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Prescription Drugs
💊 Drugs • 12,141 recalls
Class I - Dangerous
Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
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
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.
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.
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
DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL, packs of 5, Rx only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-212-92
Fresenius Medical Care Holdings
Class I - Dangerous
Temperature Abuse: Product exposed to temperature outside specified limits.
DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low Calcium, packaged in a) 3000 mL 2 packs (NDC 49230-0209-23), b) 3000 mL (NDC 49230-209-30) and c) 5000 mL (NDC 49230-209-50) Rx only, Fresenius Medical Care NA Waltham, MA 02451
Fresenius Medical Care Holdings
Class I - Dangerous
Temperature Abuse: Product exposed to temperature outside specified limits.
Class I - Dangerous
Labeling; Wrong Barcode; error in the machine-readable barcode which could result in some units being read as Naproxen Tablets 500 mg. Product is labeled correctly as Levetiracetam
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium, packaged in a) 3000 mL bags (NDC 49230-206-30) and b) 5000mL bags, 2 packs (NDC 49230-206-50), Rx only, Fresenius Medical Care NA, Waltham, MA 02451
Fresenius Medical Care Holdings
Class I - Dangerous
Temperature Abuse: Product exposed to temperature outside specified limits.