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.
- 2018-11-07FDA-DrugPharm D Solutions, LLCClass IIBacteriostatic Water for Injection 10 mL, Pharm D Solutions, Houston, Texas --- NDC 69699-1417-10
Lack of Assurance of Sterility
- 2018-11-07FDA-DrugPharm D Solutions, LLCClass IIBeta-complex B-1, B-6, B-3, B-12, B-5 100, 2.54 Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1611-30
Lack of Assurance of Sterility
- 2018-11-07FDA-DrugPharm D Solutions, LLCClass IIAscorbic Acid 500 mg/mL Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1502-50
Lack of Assurance of Sterility
- 2018-11-07FDA-DrugPharm D Solutions, LLCClass IIArginine Injections 100 mcg/mL, Pharm D Solutions, Houston, Texas NDC 69699-1414-20
Lack of Assurance of Sterility
- 2018-11-07FDA-DrugPharm D Solutions, LLCClass IIAcetylcysteine Injection 10 mg/5 mL (2 mg/mL), Pharm D Solutions, Houston, Texas ---- NDC 69699-1424-10
Lack of Assurance of Sterility
- 2018-11-07FDA-DrugAvella of Deer Valley, Inc. Store 38Class IIPhenylephrine 30 mg added to NS 250 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38
Lack of assurance of sterility
- 2018-11-07FDA-DrugAvella of Deer Valley, Inc. Store 38Class IIPhenylephrine 25 mg added to NS 250 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38
Lack of assurance of sterility
- 2018-11-07FDA-DrugAvella of Deer Valley, Inc. Store 38Class IIHydromorphone (0.2 mg/mL) in NS 100 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38
Lack of assurance of sterility
- 2018-11-07FDA-DrugAvella of Deer Valley, Inc. Store 38Class IIFentanyl (10 mcg/mL) in NS 1 mL (in 3mL BD Syringe), Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38
Lack of assurance of sterility
- 2018-11-07FDA-DrugAvella of Deer Valley, Inc. Store 38Class IIMorphine (1 mg/mL) in NS 100 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38
Lack of assurance of sterility
- 2018-11-07FDA-DrugBoehringer Ingelheim Pharmaceuticals, Inc.Class IICatapres .2 (clonidine hydrochloride, USP) 0.2mg, 100-count bottles, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. Made in Germany. NDC 0597-0007-01
Failed Dissolution Specifications: OOS resultsduring routine stability testing
- 2018-11-07FDA-DrugAurobindo Pharma Limited (Unit I)Class IIIrbesartan Bulk Active Pharmaceutical Ingredient.
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
- 2018-11-07FDA-DrugSprayologyClass IIDiet Power, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-0004-1
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- 2018-11-07FDA-DrugSprayologyClass IIBody Balance, Homeopathic Oral Spray 1.38 fl. oz (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-0039-1
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- 2018-11-07FDA-DrugSprayologyClass IIAcne Tonic Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-0027-1
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- 2018-11-07FDA-DrugSprayologyClass IIBody Skin Tonic, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-0017-1
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- 2018-11-07FDA-DrugSprayologyClass IIImmunoBooster, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-0038-1
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- 2018-11-07FDA-DrugSprayologyClass IILife Detoxer Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879NDC 61096-0023-1 and Tester NDC 61096-1023-1
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- 2018-11-07FDA-DrugSprayologyClass IIPMS Support, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0031-1
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- 2018-11-07FDA-DrugSprayologyClass IIStress Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0006-1 and Tester NDC 61096-1006-1
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- 2018-11-07FDA-DrugSprayologyClass IISnore Soother, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0024-1
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- 2018-11-07FDA-DrugSprayologyClass IIArnica Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879.NDC 61096-0032-1
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- 2018-11-07FDA-DrugSprayologyClass IIParty Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0030-1 and Tester NDC 61096-1030-1
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- 2018-11-07FDA-DrugSprayologyClass IITravelEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879NDC 61096-0007-1. and Tester NDC 61096-1007-1
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- 2018-11-07FDA-DrugSprayologyClass IISleepEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879.NDC 61096-0001-1 and Tester NDC 6196-1001-1
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- 2018-11-07FDA-DrugSprayologyClass IIDigestivEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879.NDC 61096-0005-1
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- 2018-11-07FDA-DrugSprayologyClass IICold + Flu Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0002-1
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- 2018-11-07FDA-DrugSprayologyClass IIAllergEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0003-1
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- 2018-11-07FDA-DrugSprayologyClass IIBone Builder, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0012-1 and Tester NDC 61096-1012-1
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- 2018-11-07FDA-DrugSprayologyClass IIMenoPower, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0014-1 and Tester NDC 61096-1014
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
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