June 30, 2021DrugsFDA
VIONA PHARMACEUTICALS INC recalls Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets, Rx only, Manufactured by: Cadila Healthcare L
Hazard: CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
June 30, 2021DrugsFDA
Bausch Health Companies, Inc. recalls Phytonadione Tablets, 5 mg, 30-count ablets, Rx only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant
Hazard: Failed Impurities/Degradation Specifications
June 30, 2021DrugsFDA
Bausch Health Companies, Inc. recalls Mephyton (Phytonadione) 5 mg tablets, 100-count tablets, Rx Only, Manufactured for: Valeant Pharmaceuticals North Americ
Hazard: Failed Impurities/Degradation Specifications
June 30, 2021DrugsFDA
Hill Dermaceuticals, Inc. recalls DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles, Rx only, Manufactured by: Hill Dermaceuticals
Hazard: Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
June 30, 2021DrugsFDA
Teligent Pharma, Inc. recalls Diflorasone Diacetate Ointment USP, 0.05%, packaged in a)15 g (NDC 52565-063-15) and b) 30 g (NDC 52565-063-30) tubes, R
Hazard: Presence of Foreign Substance: Foreign particles observed during routine stability testing.
June 30, 2021DrugsFDA
Miracle 8989 recalls maXXzen Platinum 12000 capsule, 1-count blister card (UPC 7 18122 04072 8), Distributed by: Maxx Inc, Los Angeles, CA 9
Hazard: Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
June 30, 2021DrugsFDA
Miracle 8989 recalls PremierZEN Platinum 8000 capsule, 1-count blister card (UPC 7 28175 42185 6), packaged in 12 cards per box (UPC 7 28175
Hazard: Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
June 30, 2021DrugsFDA
Miracle 8989 recalls PremierZEN Gold 7000 capsule, 1-count blister card, packaged in 12 cards per box (UPC 7 28175 42183 2), Distributed by:
Hazard: Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
June 23, 2021DrugsFDA
Prisma Health Outsourcing Facility recalls Ketamine HCl Injection Solution, 10 mg / 2 mL (5 mg/mL), Rx Only, Compounded by Prisma Health Outsourcing Facility 1071
Hazard: Labeling: Incorrect Exp. Date: Incorrect BUD.
June 23, 2021DrugsFDA
World Source Llc recalls QiYu Hand Sanitizer Gel, ethanol, 500 mL bottles (pump), Manufacturer Guangzhou Minghui Cosmetics Co., Ltd., Baiyun Dist
Hazard: Subpotent
June 23, 2021DrugsFDA
AVKARE Inc. recalls Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. NDC 50268-6
Hazard: Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.
June 23, 2021DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Atorvastatin Calcium Tablets, USP 10 mg, 500-count bottles, Rx Only, Dr. Reddy's Mfd. By: Dr. Reddy's Laboratories Limit
Hazard: Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities
June 23, 2021DrugsFDA
DASH XCLUSIVE recalls Imperia Elita Vitaccino Coffee, 10 g sachets, 15 sachets per box, Global Beauty Technologies, Manufactured for: Imperia-
Hazard: Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ingredients Sibutramine and Fluoxetine
June 16, 2021DrugsFDA
McKesson Corporation dba McKesson Drug Company recalls Levetiracetam Tablets USP, 250 mg UD 100 Tablets (10x10) boxes, Rx Only, Distributed By: McKesson Corporation 4971 South
Hazard: 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
June 16, 2021DrugsFDA
Medline Industries Inc recalls READYPREP CHG, 2% Chlorhexidine Gluconate Cloth, 2 9x10.5 in (22.9x26.7 cm) Disposable Cloths, Non-Sterile, Single Use O
Hazard: Superpotent Drug: Product is above specification for active ingredient, 2% Chlorhexidine Gluconate.
June 16, 2021DrugsFDA
Fresenius Medical Care Holdings, Inc. recalls DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium, packaged in a) 3000 mL bags (NDC 49
Hazard: Temperature Abuse: Product exposed to temperature outside specified limits.
June 16, 2021DrugsFDA
Fresenius Medical Care Holdings, Inc. recalls DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set
Hazard: Temperature Abuse: Product exposed to temperature outside specified limits.
June 16, 2021DrugsFDA
Fresenius Medical Care Holdings, Inc. recalls DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set,
Hazard: Temperature Abuse: Product exposed to temperature outside specified limits.
June 16, 2021DrugsFDA
Fresenius Medical Care Holdings, Inc. recalls DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set,
Hazard: Temperature Abuse: Product exposed to temperature outside specified limits.
June 16, 2021DrugsFDA
Fresenius Medical Care Holdings, Inc. recalls DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low Calcium, 5000 mL, Fresenius Medical Care, W
Hazard: Temperature Abuse: Product exposed to temperature outside specified limits.
June 16, 2021DrugsFDA
Fresenius Medical Care Holdings, Inc. recalls DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low Calcium, packaged in a) 3000 mL 2 packs (ND
Hazard: Temperature Abuse: Product exposed to temperature outside specified limits.
June 16, 2021DrugsFDA
Fresenius Medical Care Holdings, Inc. recalls DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care NA, Walth
Hazard: Temperature Abuse: Product exposed to temperature outside specified limits.
June 16, 2021DrugsFDA
Fresenius Medical Care Holdings, Inc. recalls Sodium Chloride 0.9%, USP, 1000 mL, Mfg by: Fresenius Medical Care North America, Waltham, MA 02451, NDC 46163-0300-10
Hazard: Temperature Abuse: Product exposed to temperature outside specified limits.
June 9, 2021DrugsFDA
PFIZER, INC recalls 1% Lidocaine HCl Injection, USP, 300 mg/30 mL (10 mg/mL), 30 mL Single-dose vial (NDC 0409-4279-16), packaged in 25 vial
Hazard: Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP
June 9, 2021DrugsFDA
PFIZER, INC recalls 0.5% Bupivacaine Hydrochloride Injection, USP, 150 mg/30 mL (5 mg/mL), 30 mL Single-dose Teartop Vials (NDC 0409-1162-19
Hazard: Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP
June 9, 2021DrugsFDA
Oxford Pharmaceuticals, LLC recalls BusPIRone Hydrochloride Tablets, USP, 15 mg, 100-count bottle, Rx only, Manufactured By: Oxford Pharmaceuticals, LLC Bir
Hazard: Presence of Foreign Tablets/Capsules
June 9, 2021DrugsFDA
Mylan Institutional LLC recalls Thiamine HCl Injection, USP 200 mg/2 mL (100mg/mL), 2 mL vials, packaged in 25 (2 mL multi-dose vial) per carton, Rx onl
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date: Cartons with the correct lot number 200906 contain vials labeled with the incorrect lot number 200901.
June 9, 2021DrugsFDA
Boehringer Ingelheim Pharmaceuticals, Inc. recalls Micardis Tablets, (telmisartan Tablets) 80 mg, 30 ct. per folding cartons, Rx only, NDC 0597-0041-37), Distributed by: B
Hazard: Subpotent Drug
June 2, 2021DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Atorvastatin Calcium Tablets, USP 10 mg*, Rx Only, 500 count bottle, Mfd By: Dr. Reddy's Laboratories Limited, Bachupall
Hazard: Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities
June 2, 2021DrugsFDA
Accupac, Inc. recalls Native Fluoride Toothpaste for Sensitive Teeth, with Fluoride, 5% potassium nitrate, 0.243% sodium fluoride (0.14% w/v f
Hazard: Labeling: Not Elsewhere Classified; the primary label (tube) may be incorrectly labeled as Fluoride-Free instead of With Fluoride