February 27, 2019DrugsFDA
Amerigen Pharmaceuticals Inc. recalls Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 43975-252-05) b) 14-count bottle (NDC 43975-252-14), Rx
Hazard: Failed dissolution specifications
February 27, 2019DrugsFDA
Akorn Inc recalls Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) and b) 60 gram (NDC 50383-270-60) tubes, Rx o
Hazard: Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.
February 27, 2019DrugsFDA
ACP Nimble Buyer, Inc. recalls Mometasone Furoate Cream, 0.1%, 45 g tube, Rx Only, Manufactured by: G&W Laboratories, Inc. South Plainfield, NJ 07080,
Hazard: Labeling: Not Elsewhere Classified. Mometasone Furoate Cream has an NDC typographical error.
February 27, 2019DrugsFDA
Lupin Pharmaceuticals Inc. recalls Lovastatin Tablets USP, 40 mg, packaged in a) 60-count (NDC 68180-469-07 and b) 100-count (NDC 68180-469-01) bottles, Rx
Hazard: CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
February 27, 2019DrugsFDA
Perrigo New York, Inc. recalls Ciclopirox shampoo 1%,120 mL bottle, Rx only, Manufactured By Perrigo Bronx, NY 10457 Distributed by Perrigo Allegan, MI
Hazard: Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing.
February 27, 2019DrugsFDA
Akorn Inc recalls Moisturizing Lubricant Eye Drops, 0.25% Sodium Carboxymethylcellulose, 0.5 Fl OZ (15mL) Distributed by: Walgreen Co, 200
Hazard: Failed Stability Specification: out of specification results for Sodium Perborate
February 27, 2019DrugsFDA
Mariposa Labs LLC recalls tubby todd Bath Co, 100% NATURAL DREAM CREAM, Shea Butter and Mint, 3.5 FL OZ 99G, Distributed by: Tubby Todd Bath Co. V
Hazard: Microbial Contamination of Non-Sterile Products: Consumer complaint and subsequent testing found lot to be out of specification for mold.
February 27, 2019DrugsFDA
ICU Medical Inc recalls 0.9% Sodium Chloride Injection, USP 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC
Hazard: CGMP Deviations
February 27, 2019DrugsFDA
US Compounding Inc recalls Ephedrine Sulfate, 50 mg/10 mL, 10 mL Single Use Syringe, Rx only, US Compounding Pharmacy 1270 Don's Lane Conway, AR 80
Hazard: Lack of assurance of sterility.
February 27, 2019DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx only, Mfd.By: Dr. Reddy's Laboratories Limi
Hazard: Failed Dissolution Specifications: Out of specification results observed for high dissolution.
February 27, 2019DrugsFDA
Mylan Pharmaceuticals Inc. recalls Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-01), and b) 500-coun
Hazard: Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing
February 27, 2019DrugsFDA
Torrent Pharma Inc. recalls LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP 50 mg/12.5 mg, a) 90-count bottle (NDC: 13668-116-90), b) 1000-
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
February 27, 2019DrugsFDA
Torrent Pharma Inc. recalls LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP, 100 mg/12.5 mg, a) 90-count bottle (NDC: 13668-117-90), b) 100
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
February 27, 2019DrugsFDA
Torrent Pharma Inc. recalls LOSARTAN POTASSIUM TABLETS, USP, 25 mg, 90-count bottle (NDC: 13668-113-90), Rx only, Manufactured by: Torrent Pharmaceu
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
February 27, 2019DrugsFDA
Torrent Pharma Inc. recalls LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count bottle (NDC: 13668-409-30), b) 90-count bottle (NDC: 13668-409-90),
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
February 27, 2019DrugsFDA
Torrent Pharma Inc. recalls LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 30-count (NDC: 13668-115-30), b) 90-count (NDC: 13668-115-90), c) 1000-count
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
February 27, 2019DrugsFDA
Advanced Pharma Inc. recalls Oxytocin 30 Units added to NS 500 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 503 mL Steri
Hazard: Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
February 27, 2019DrugsFDA
Advanced Pharma Inc. recalls Oxytocin 20 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1002 mL Ste
Hazard: Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
February 27, 2019DrugsFDA
Advanced Pharma Inc. recalls Oxytocin 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1001 mL Ste
Hazard: Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
February 27, 2019DrugsFDA
Advanced Pharma Inc. recalls Fentanyl in 0.9% Sodium Chloride QS 0.5 mL, 5 mcg/0.5 mL with up to 0.1 mL of overfill Injectable Solution, Sterile sing
Hazard: Labeling: Incorrect expiration date.
February 20, 2019DrugsFDA
Avella of Deer Valley, Inc. Store 38 recalls MAGnesium 2 gm sulfate, added to NS 50 mL, Sterile single use bag, 54 mL, Compounded by Avella Specialty Pharmacy 24416
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself.
February 20, 2019DrugsFDA
Avella of Deer Valley, Inc. Store 38 recalls MAGnesium 2gm sulfate, added to D5W 50 mL, Volume: 54 mL, Sterile single use bag, Compounded by Avella Specialty Pharma
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself.
February 20, 2019DrugsFDA
Avella of Deer Valley, Inc. Store 38 recalls MAGnesium 1gm sulfate, added to D5W 50 mL, Volume 52 mL, sterile single use bag, Compounded by Avella Specialty Pharmac
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself.
February 20, 2019DrugsFDA
Avella of Deer Valley, Inc. Store 38 recalls Labetalol 20mg, HCL, USP Injectable Solution, 20mg/4mL (5 mg per mL), 4mL single use syringe. Repackaged by Avella Speci
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself.
February 20, 2019DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg*, a) 90-count bottle (NDC 43598-510-90) b) 1000 count bottle (
Hazard: Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.
February 20, 2019DrugsFDA
Tris Pharma Inc. recalls Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berr
Hazard: Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
February 20, 2019DrugsFDA
Tris Pharma Inc. recalls infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 1 FL
Hazard: Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
February 20, 2019DrugsFDA
Tris Pharma Inc. recalls Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berr
Hazard: Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
February 20, 2019DrugsFDA
Oxalis Labs recalls Clobetasol Propionate Topical Solution USP, 0.05% w/w, 50 mL bottle, Manufactured for: Macleods Pharma USA, Inc. Plains
Hazard: Defective Container; complaints of leakage.
February 20, 2019DrugsFDA
Valeant Pharmaceuticals North America LLC recalls Diltiazem HCl CD capsules, 360 mg, 90-count bottles, Rx Only, Manufactured for: Oceanside Pharmaceuticals, a division of
Hazard: Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.