October 23, 2019DrugsFDA
Aurobindo Pharma USA Inc. recalls Dextroamphetamine Sacharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, Mixed Sal
Hazard: Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness.
October 23, 2019DrugsFDA
KVK-Tech, Inc. recalls Methylphenidate Hydrochloride Oral Solution 5mg per 5mL, 500 mL Bottle, Sugar Free Alcohol Free, Rx Only, Mfd by: KVK Te
Hazard: Presence of Foreign Substance; Fiber particles.
October 23, 2019DrugsFDA
Spectrum Laboratory Products recalls Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-0
Hazard: CGMP Deviations: Received notice from supplier that there is potential glass contamination.
October 23, 2019DrugsFDA
Macleods Pharma Usa Inc recalls Pioglitazone Hydrochloride Tablets USP 15 mg, 30 count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Pl
Hazard: Superpotent
October 16, 2019DrugsFDA
Mylan Laboratories Limited (Sterile Products Division) recalls Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103; NDC 6
Hazard: Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity results which could decrease the effectiveness of the product.
October 16, 2019DrugsFDA
GUERBET LLC recalls Sodium Chloride Injection USP 0.9%, packaged in 1 - 125 mL Ultraject Prefilled Syringe For Power Injection per carton, R
Hazard: Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syringe as expired and will not allow injection of product by the Optivantage injector.
October 16, 2019DrugsFDA
GUERBET LLC recalls Optiray 320 (ioversol) Injection 68%, 320 mg/mL Organically Bound Iodine, packaged in 1 - 100 mL Ultraject Prefilled Syr
Hazard: Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syringe as expired and will not allow injection of product by the Optivantage injector.
October 16, 2019DrugsFDA
Pfizer Inc. recalls 10% LMD in 5% Dextrose Injection Dextran 40 in Dextrose Injection, USP, 500 mL bags, Rx only, Hospira, Inc., Lake Fores
Hazard: Lack of Assurance of Sterility: Bag has the potential to leak.
October 16, 2019DrugsFDA
Epic Pharma, LLC recalls Estradiol tablets, 0.5 mg, 100-count bottles, Rx only, Distributed by Epic Pharma, LLC Laurelton, NY 11413, NDC 42806-0
Hazard: Presence of Foreign Tablets/Capsules: Estradiol 1 mg was found in a 100 count bottle of Estradiol 0.5 mg Tablets.
October 16, 2019DrugsFDA
Amneal Pharmaceuticals, Inc. recalls Benazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ N
Hazard: Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle
October 16, 2019DrugsFDA
Unipharma, Llc. recalls DrKids Himasal Natural Nasal Saline Solution, packaged in Pre-measured Singe-Use Vials a) 0.5 mL Each (20 count) UPC 3
Hazard: CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
October 16, 2019DrugsFDA
Unipharma, Llc. recalls DrKids Children's Natural Cough Syrup English Ivy Leaf, packaged in Pre-measured Single-Use Vials 0.17 fl. oz. (5 mL) Ea
Hazard: CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
October 16, 2019DrugsFDA
Teva Pharmaceuticals USA recalls Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30 count bottle, Rx only, Manufactured by: Actabis
Hazard: GMP Deviation: lot not intended for commercial distribution.
October 16, 2019DrugsFDA
Morton Grove Pharmaceuticals, Inc. recalls Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in a 8 fl oz (237 mL) bottle, Rx only, Manufactured By
Hazard: Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14
October 16, 2019DrugsFDA
Sandoz, Inc recalls Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Produ
Hazard: CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
October 16, 2019DrugsFDA
Sandoz, Inc recalls Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Prod
Hazard: CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
October 16, 2019DrugsFDA
Sandoz, Inc recalls Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ Product of
Hazard: CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
October 16, 2019DrugsFDA
GCP Laboratories Inc recalls Major Infants' Gas Relief Drops, Simethicone Oral Suspension USP, 1 FL OZ (30 mL) bottle, Distributed by: Major Pharmace
Hazard: Microbial Contamination of Non-Sterile Product.
October 9, 2019DrugsFDA
Akorn, Inc. recalls Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL
Hazard: Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the sterility of the product.
October 9, 2019DrugsFDA
Torrent Pharma Inc. recalls Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets per bottle, Rx Only, Manufactured for: Torre
Hazard: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.
October 9, 2019DrugsFDA
Torrent Pharma Inc. recalls Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 tablets per bottle, Rx Only, Manufactured for: Tor
Hazard: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.
October 9, 2019DrugsFDA
Torrent Pharma Inc. recalls Losartan Potassium Tablets, USP 100 mg, [90 or 1000] tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc.
Hazard: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.
October 9, 2019DrugsFDA
Torrent Pharma Inc. recalls Losartan Potassium Tablets, USP 50mg, 1000 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking
Hazard: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.
October 9, 2019DrugsFDA
Alkermes, Inc. recalls Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial. Each Carton Contains: 1) One vial of 380 m
Hazard: Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product vial is not impacted.
October 9, 2019DrugsFDA
KRS Global Biotechnology, Inc recalls Isoproterenol HCL (PF) in D5W, 200 mcg / 50 mL (4 mcg/mL), 50 mL IV Bag, Single Dose Only, Contains Sulfites, For Slow I
Hazard: Lack of Assurance of Sterility
October 9, 2019DrugsFDA
KRS Global Biotechnology, Inc recalls L-Asparaginase Lyophilized, 10,000 International Units/Vial, For IV / IM / SC Use, Rx Only, KRS Global Biotechnology 791
Hazard: Lack of Assurance of Sterility
October 9, 2019DrugsFDA
KRS Global Biotechnology, Inc recalls Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 10% (100 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac Tromethamin
Hazard: Lack of Assurance of Sterility
October 9, 2019DrugsFDA
KRS Global Biotechnology, Inc recalls Vitamin B1/B2/B3/B6/HYDROXOCOBALAMIN 66/1.33/66/66/0.66 mg/mL (PF), For IV Use, 3 mL fill in a 5 mL Single Dose Vial, Rx
Hazard: Lack of Assurance of Sterility
October 9, 2019DrugsFDA
KRS Global Biotechnology, Inc recalls Vitamin 9A/B Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 3
Hazard: Lack of Assurance of Sterility
October 9, 2019DrugsFDA
KRS Global Biotechnology, Inc recalls Vitamin 9 Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 3348
Hazard: Lack of Assurance of Sterility