Drug and pharmaceutical recalls
17624 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-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.
- 2018-11-07FDA-DrugSprayologyClass IIWoman Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879 NDC 61096-0034-1 and Tester NDC 61096-1034-1
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- 2018-11-07FDA-DrugSprayologyClass IIBrain Power,Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0033-1
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- 2018-11-07FDA-DrugSprayologyClass IIMan Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0025-1 and Tester NDC 61096-1025-1
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- 2018-11-07FDA-DrugSprayologyClass IIRejuvenation Plus, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879 NDC 61096-0035-1
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- 2018-10-31FDA-DrugUpsher Smith Laboratories, Inc.Class IIBumetanide Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0542-11
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
- 2018-10-31FDA-DrugUpsher Smith Laboratories, Inc.Class IIBumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0541-11
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
- 2018-10-31FDA-DrugPromise Pharmacy LLCClass IIIPrednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 US Hwy 19N, Palm Harbor, FL 34684
Presence of precipitate
- 2018-10-31FDA-DrugRXQ Compounding LLCClass IILidocaine 1% + Epinephrine 1:100,000 (MDV) INJ SOL, 50 mL per glass vial, Rx only, 340 West State Street, Unit 9, Athens, OH 45701. NDC 7073197450
Subpotent drug: During testing of the retention sample, the firm discovered that the product was sub-potent.
- 2018-10-31FDA-DrugTeva Pharmaceuticals USAClass IIMetoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 62037-831-01
Failed dissolution specifications: Out-of-Specification dissolution test result obtained during routine stability testing.
- 2018-10-31FDA-DrugTeva Pharmaceuticals USAClass IIPIO&METFORMIN 15/1000 mg Tab 1 (Pioglitazone and Metformin XT) tablets, Takeda Brand Name: Actoplus Met XR (Pioglitazone and metformin HCl extended -release) tablets, 15 mg/1000 mg, packaged in a fiber drum, Application Holder Takeda Pharmaceuticals, U.S.A. Inc. One Takeda Parkway, Deerfield, IL 60015
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
- 2018-10-31FDA-DrugTeva Pharmaceuticals USAClass IIMetformin Hydrochloride Extended Release Tablets 1000 mg, 90-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 , NDC 00591-2412-19
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
- 2018-10-31FDA-DrugTeva Pharmaceuticals USAClass IIMetformin Hydrochloride Extended Release Tablets 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 , NDC 00591-2720-60
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
- 2018-10-31FDA-DrugTeva Pharmaceuticals USAClass IIMetformin Hydrochloride Extended Release Tablets, 500 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories, FL Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 00591-2411-01
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
- 2018-10-31FDA-DrugTeva Pharmaceuticals USAClass IIFortamet (metformin HCl) extended release tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Shionogi Inc., Florham Park, NJ 07932, NDC 59630-575-60
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
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