Drug and pharmaceutical recalls
17728 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2019-03-27FDA-DrugCamber Pharmaceuticals IncClass IILosartan Potassium Tablets USP, 50 mg, Rx only, a) 30 count (NDC 31722-701-30), b) 90 count (NDC 31722-701-90), c) 1000 count (NDC 31722-701-10) bottles, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar -509 301, India
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
- 2019-03-27FDA-DrugCamber Pharmaceuticals IncClass IILosartan Potassium Tablets USP, 25 mg, Rx only, a) 90 count (NDC 31722-700-90), b) 500 count (NDC 31722-700-05) and c) 1000 count (NDC 31722-700-05) bottles, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar -509 301, India
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
- 2019-03-27FDA-DrugMacleods Pharma Usa IncClass IILosartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India. NDC 33342-0052-10
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
- 2019-03-27FDA-DrugAurobindo Pharma USA Inc.Class IIValsartan Tablets USP 160 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-572-90
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
- 2019-03-27FDA-DrugAurobindo Pharma USA Inc.Class IIValsartan Tablets USP 80 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-571-90
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
- 2019-03-27FDA-DrugAurobindo Pharma USA Inc.Class IIValsartan Tablets USP 40 mg, 30 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-570-30
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
- 2019-03-27FDA-DrugAurobindo Pharma USA Inc.Class IIAmlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ Manufactured by: Aurobindo Pharma Limited, India --- NDC 65862-739-30
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
- 2019-03-27FDA-DrugAurobindo Pharma USA Inc.Class IIValsartan Tablets USP 320 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-573-90
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
- 2019-03-27FDA-DrugAdvanced Pharma Inc.Class IIPhenylephrine HCl, 1,200 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1,200 mcg/10 mL (120 mcg per mL), Sterile single use syringe, NDC: 42852-882-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
Lack of Assurance of Sterility
- 2019-03-27FDA-DrugAdvanced Pharma Inc.Class IIMorphine Sulfate 30 mg/30 mL (1 mg/mL) Injectable Solution Morphine Sulfate 30 mg 0.9% Sodium Chloride QS 30 mL Sterile singe use syringe, NDC: 42852-241-63 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
Lack of Assurance of Sterility
- 2019-03-27FDA-DrugAdvanced Pharma Inc.Class IIPhenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg per mL) NDC: 42852-802-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
Lack of Assurance of Sterility
- 2019-03-27FDA-DrugAdvanced Pharma Inc.Class IIHeparin 5,000 Units/5mL (1,000 Units per mL) Injectable Solution, 5,000 Units in 0.9% Sodium Chloride, QS 5 mL Sterile single use syringe, NDC: 42852-739-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
Lack of Assurance of Sterility
- 2019-03-27FDA-DrugAdvanced Pharma Inc.Class IIHeparin 10 Units/10 mL 10 Units in 0.45% Sodium Chloride, QS 10 mL, Injectable Solution, Dwell, 10mL Sterile single use syringe, NDC: 42852-725-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
Lack of Assurance of Sterility
- 2019-03-27FDA-DrugAdvanced Pharma Inc.Class IIEsmolol HCl Injectable Solution 100 mg/10 mL (10 mg per mL)10mL Sterile single use syringe, NDC: 42852-827-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
Lack of Assurance of Sterility
- 2019-03-27FDA-DrugAdvanced Pharma Inc.Class IIPhenylephrine HCl, 800 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution, 800 mcg/10 mL (80 mcg per mL), 10mL Sterile single use syringe, NDC: 42852-865-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
Lack of Assurance of Sterility
- 2019-03-27FDA-DrugAdvanced Pharma Inc.Class II2% Lidocaine HCl Injectable Solution, 100 mg/5 mL (20 mg per mL), 5mL Sterile single use syringe, NDC: 42852-011-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
Lack of Assurance of Sterility
- 2019-03-27FDA-DrugAdvanced Pharma Inc.Class II2% Lidocaine HCl Injectable Solution, 60 mg/3 mL (20 mg per mL), 3mL Sterile single use syringe, NDC: 42852-011-22 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
Lack of Assurance of Sterility
- 2019-03-27FDA-DrugAdvanced Pharma Inc.Class IIGlycopyrrolate 0.6 mg/3 mL (0.2 mg per mL) Injectable Solution, 3 mL Sterile single use syringe, For IV or IM use, NDC: 42852-828-22 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
Lack of Assurance of Sterility
- 2019-03-27FDA-DrugAdvanced Pharma Inc.Class IINeostigmine Methylsulfate Injection Solution 5 mg/5mL (1 mg per mL), 5mL Sterile single use syringe, For IV use only, NDC: 42852-829-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
Lack of Assurance of Sterility
- 2019-03-27FDA-DrugAdvanced Pharma Inc.Class IIPhenylephrine HCl, 1 mg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg per mL), Sterile single use syringe, NDC: 42852-830-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
Lack of Assurance of Sterility
- 2019-03-27FDA-DrugAdvanced Pharma Inc.Class IIPhenylephrine HCl, 400 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 400 mcg/10 mL (40 mcg per mL), Sterile single use syringe, NDC: 42852-876-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
Lack of Assurance of Sterility
- 2019-03-27FDA-DrugAdvanced Pharma Inc.Class IIGlycopyrrolate Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single use syringe, NDC: 42852-828-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
Lack of Assurance of Sterility
- 2019-03-27FDA-DrugAdvanced Pharma Inc.Class IIPhenylephrine HCl, 500 mcg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 500 mcg/5 mL (100 mcg per mL), 5mL Sterile single use syringe, NDC: 42852-830-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
Lack of Assurance of Sterility
- 2019-03-27FDA-DrugAdvanced Pharma Inc.Class IIMidazolam Benzodiazepine 50 mg/50 mL (1 mg/mL) Injectable Solution, Midazolam HCl 0.9% Sodium Chloride, QS, Sterile single use bag, NDC: 42852-401-05 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
Lack of Assurance of Sterility
- 2019-03-27FDA-DrugAdvanced Pharma Inc.Class IIfentaNYL 2500 mcg/250 mL Injectable Solution, Fentanyl 0.9% Sodium Chloride, QS, Sterile single use bags, NDC: 42852-210-25 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
Lack of Assurance of Sterility
- 2019-03-27FDA-DrugAdvanced Pharma Inc.Class IIfentaNYL 1000 mcg/100 mL Injectable Solution Fentanyl 0.9% Sodium Chloride, QS, 100 mL, Sterile single use bag, NDC: 42852-210-10 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
Lack of Assurance of Sterility
- 2019-03-27FDA-DrugAdvanced Pharma Inc.Class IIHYDROmorphone HCl 1 mg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single use syringe, NDC: 42852-289-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
Lack of Assurance of Sterility
- 2019-03-27FDA-DrugMylan Institutional, Inc. (d.b.a. UDL Laboratories)Class IIAlprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-788-20
Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected during 6-month RT stability interval.
- 2019-03-27FDA-DrugAkorn IncClass IIHydrocortisone and Acetic Acid Otic Solution, USP, 10 mL per dropper bottle, Rx only, Hi-Tech Pharmacal Co, Inc., Amityville, NY 11701. NDC: 50383-901-10
Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature.
- 2019-03-27FDA-DrugLupin Pharmaceuticals Inc.Class IIITestosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC 68180-943-11
Defective Container: Repetitive complaints received indicating pump not working.
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