March 27, 2019DrugsFDA
Advanced Pharma Inc. recalls Heparin 5,000 Units/5mL (1,000 Units per mL) Injectable Solution, 5,000 Units in 0.9% Sodium Chloride, QS 5 mL Sterile s
Hazard: Lack of Assurance of Sterility
March 27, 2019DrugsFDA
Advanced Pharma Inc. recalls Heparin 10 Units/10 mL 10 Units in 0.45% Sodium Chloride, QS 10 mL, Injectable Solution, Dwell, 10mL Sterile single use
Hazard: Lack of Assurance of Sterility
March 27, 2019DrugsFDA
Advanced Pharma Inc. recalls Esmolol HCl Injectable Solution 100 mg/10 mL (10 mg per mL)10mL Sterile single use syringe, NDC: 42852-827-61 Avella of
Hazard: Lack of Assurance of Sterility
March 27, 2019DrugsFDA
Advanced Pharma Inc. recalls Phenylephrine HCl, 800 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution, 800 mcg/10 mL (80 mcg per mL), 10mL S
Hazard: Lack of Assurance of Sterility
March 27, 2019DrugsFDA
Advanced Pharma Inc. recalls 2% Lidocaine HCl Injectable Solution, 100 mg/5 mL (20 mg per mL), 5mL Sterile single use syringe, NDC: 42852-011-67 Avel
Hazard: Lack of Assurance of Sterility
March 27, 2019DrugsFDA
Advanced Pharma Inc. recalls 2% Lidocaine HCl Injectable Solution, 60 mg/3 mL (20 mg per mL), 3mL Sterile single use syringe, NDC: 42852-011-22 Avell
Hazard: Lack of Assurance of Sterility
March 27, 2019DrugsFDA
Advanced Pharma Inc. recalls Glycopyrrolate 0.6 mg/3 mL (0.2 mg per mL) Injectable Solution, 3 mL Sterile single use syringe, For IV or IM use, NDC:
Hazard: Lack of Assurance of Sterility
March 27, 2019DrugsFDA
Advanced Pharma Inc. recalls Neostigmine Methylsulfate Injection Solution 5 mg/5mL (1 mg per mL), 5mL Sterile single use syringe, For IV use only, ND
Hazard: Lack of Assurance of Sterility
March 27, 2019DrugsFDA
Advanced Pharma Inc. recalls Phenylephrine HCl, 1 mg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg per mL), Sterile singl
Hazard: Lack of Assurance of Sterility
March 27, 2019DrugsFDA
Advanced Pharma Inc. recalls Phenylephrine HCl, 400 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 400 mcg/10 mL (40 mcg per mL), Sterile
Hazard: Lack of Assurance of Sterility
March 27, 2019DrugsFDA
Advanced Pharma Inc. recalls Glycopyrrolate Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single use syringe, NDC: 42852-828-67 Avella of Ho
Hazard: Lack of Assurance of Sterility
March 27, 2019DrugsFDA
Advanced Pharma Inc. recalls Phenylephrine HCl, 500 mcg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 500 mcg/5 mL (100 mcg per mL), 5mL Steri
Hazard: Lack of Assurance of Sterility
March 27, 2019DrugsFDA
Advanced Pharma Inc. recalls Midazolam Benzodiazepine 50 mg/50 mL (1 mg/mL) Injectable Solution, Midazolam HCl 0.9% Sodium Chloride, QS, Sterile sing
Hazard: Lack of Assurance of Sterility
March 27, 2019DrugsFDA
Advanced Pharma Inc. recalls fentaNYL 2500 mcg/250 mL Injectable Solution, Fentanyl 0.9% Sodium Chloride, QS, Sterile single use bags, NDC: 42852-210
Hazard: Lack of Assurance of Sterility
March 27, 2019DrugsFDA
Advanced Pharma Inc. recalls fentaNYL 1000 mcg/100 mL Injectable Solution Fentanyl 0.9% Sodium Chloride, QS, 100 mL, Sterile single use bag, NDC: 428
Hazard: Lack of Assurance of Sterility
March 27, 2019DrugsFDA
Advanced Pharma Inc. recalls HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single us
Hazard: Lack of Assurance of Sterility
March 27, 2019DrugsFDA
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, W
Hazard: Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected during 6-month RT stability interval.
March 27, 2019DrugsFDA
Akorn Inc recalls Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL per dropper bottle, Rx only, Hi-Tech Pharmacal Co, Inc., Amityv
Hazard: Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature.
March 27, 2019DrugsFDA
Lupin Pharmaceuticals Inc. recalls Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimor
Hazard: Defective Container: Repetitive complaints received indicating pump not working.
March 27, 2019DrugsFDA
Iso-Tex Diagnostics, Inc recalls Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY, NY;
Hazard: Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.
March 27, 2019DrugsFDA
Rx Pak Division of McKesson Corporation recalls Docusate Sodium, 100mg softgels, packaged in 10 x 10 unit dose blister cards, For institutional use only, Mfg by: Aenova
Hazard: Labeling: Label mix-up: Secondary carton may be labeled as Gabapentin 300mg instead of Docusate Sodium 100mg softgel caps.
March 27, 2019DrugsFDA
Teva Pharmaceuticals USA recalls Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100 tablets (10 blister cards of 10 tablets each), Rx
Hazard: Subpotent Drug.
March 20, 2019DrugsFDA
Mylan Institutional Inc recalls Levoleucovorin Injection, 250 mg/25 mL, (10 mg/mL), 25 mL Single-Use Vial, Rx only, Manufactured for: Mylan Institution
Hazard: Presence of Particulate Matter: particulate matter identified as copper salts
March 20, 2019DrugsFDA
Medtech Products, Inc. recalls Little Remedies New Baby Essentials Kit. Each kit contains 1 each of the following products: Little Remedies Infant Feve
Hazard: Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit.
March 20, 2019DrugsFDA
Golean Detox US recalls Golean DETOX capsules, 14 Net: 56 g, 14 packets containing 2 capsules per packet, 28-count capsules per box, MAT XI S.G
Hazard: Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain undeclared sibutramine and phenolphthalein. Sibutramine is an appetite suppressant that was withdrawn from the US market due to safety concerns. Phenolphthalein was once an ingredient used in over-the-counter laxatives, but because of concerns of carcinogenicity is not currently approved for marketing in the US. The presence of sibutramine and phenolphthalein in this product renders it an unapproved drug for which the safety and efficacy has not been established and, therefore, subject to recall.
March 20, 2019DrugsFDA
Macleods Pharma Usa Inc recalls Telmisartan and Hyrdochlorothiazide Tablets 80 mg/25 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma US
Hazard: Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
March 20, 2019DrugsFDA
Macleods Pharma Usa Inc recalls Telmisartan and Hyrdochlorothiazide Tablets, USP 80mg/12.5 mg, 30-coun bottles, Rx Only, Manufactured for: Macleods Phar
Hazard: Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
March 20, 2019DrugsFDA
Macleods Pharma Usa Inc recalls Telmisartan and Hyrdochlorothiazide Tablets 40mg/12.5 mg, 30-count bottles, Rx Only, Manufactured for:Macleods Pharma
Hazard: Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
March 20, 2019DrugsFDA
Roberts Home Medical LLC recalls Oxygen, Refrigerated Liquid USP, Rx only, cylinder, a) Roberts Home Medical, Inc. Rockville MD 20855, b) Roberts Home Me
Hazard: CGMP Deviations
March 20, 2019DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Docetaxel Injection USP, 80 mg/4 mL, (20 mg/mL), One-Vial Formulation, Rx only, Mfd By: Dr. Reddy's Laboratories Limited
Hazard: Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance.