Drug and pharmaceutical recalls
17730 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2016-12-21FDA-DrugCantrell Drug CompanyClass IICalcium Chloride 1 g/50 mL* Added to 5% Dextrose (20 mg/mL)*, Single-Dose Bag, Rx Only, Hospital/Office Use Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-175-37
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
- 2016-12-14FDA-DrugNorth American Rescue LLC.Class IIUSCG Boat Response Kit - Product Code 80-0353, North American Rescue
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
- 2016-12-14FDA-DrugNorth American Rescue LLC.Class IIAid Backpack Kit - Product Code 85-0917, North American Rescue
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
- 2016-12-14FDA-DrugNorth American Rescue LLC.Class IIMini Resupply Trauma Kit - Product Code 85-0835, North American Rescue
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
- 2016-12-14FDA-DrugNorth American Rescue LLC.Class IIAmphibious Trauma Kit - Product Code 85-0639, North American Rescue
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
- 2016-12-14FDA-DrugNorth American Rescue LLC.Class IIK-9 Trauma Field Kit - Product Code 80-0211, 80-0304, 80-0209, 80-0210, 80-0300, 80-0301, North American Rescue
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
- 2016-12-14FDA-DrugNorth American Rescue LLC.Class IIAdvance Trauma Kit - Product Code 85-0742, 85-0746, 85-0745, 85-0639, 85-0744, 85-0744, 85-0741, North American Rescue
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
- 2016-12-14FDA-DrugNorth American Rescue LLC.Class IIRange Trauma Kit - Product Code 85-1274, North American Rescue
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
- 2016-12-14FDA-DrugNorth American Rescue LLC.Class IIRange Trauma Kit ORG - Product Code 80-0213, 80-0299, 80-0298, North American Rescue
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
- 2016-12-14FDA-DrugNorth American Rescue LLC.Class IIRange Trauma Kit Hardcase - Product Code 85-0889, North American Rescue
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
- 2016-12-14FDA-DrugFallon Wellness Pharmacy, L.L.C.Class IIPAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 30 mg/4 mg/0.04 mg/mL Injection, 1 mL vials, Fallon Wellness Pharmacy LLC, 1057 Troy-Schenectady Rd, Latham, NY 12110.
Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.
- 2016-12-14FDA-DrugFallon Wellness Pharmacy, L.L.C.Class IIPAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 18 mg/0.6 mg/0.006 mg/mL Injection, 1 mL vials, Fallon Wellness Pharmacy LLC, 1057 Troy-Schenectady Rd, Latham, NY 12110.
Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.
- 2016-12-14FDA-DrugWest-Ward Pharmaceuticals Corp.Class IIISODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 62.5mg elemental iron/5mL, 10 (5mL vials) per shelf pack, Rx only, Mfd: Hikma Farmaceutica (Portugal,) SA Distributed by: Westward Eatowntown NJ 07724 USA, Shelf pack NDC 0143-9570-10, Unit dose NDC 0143-9570-01
Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.
- 2016-12-14FDA-DrugTeva Pharmaceuticals USAClass IIIQnasl (beclomethasone dipropionate) Nasal Aerosol 80 Mcg, 50 Metered Sprays, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044, By: 3M Drug Delivery Systems, Northridge, CA 91324, NDC 59310-210-13.
Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.
- 2016-12-14FDA-DrugTeva Pharmaceuticals USAClass IIIQnasl (beclomethasone dipropionate) Nasal Aerosol 40 Mcg, 60 Metered Sprays, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044, By: 3M Drug Delivery Systems, Northridge, CA 91324, NDC 59310-206-06 and 59310-206-08 (Physician Samples).
Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.
- 2016-12-14FDA-DrugHospira Inc.Class III5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Single-dose ampule, 5 count box, Rx Only, For Spinal Anesthesia Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4712-01
Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.
- 2016-12-07FDA-DrugNationwide Laboratories, LLCClass IIPhenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830, NDC 42937-702-10.
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
- 2016-12-07FDA-DrugNationwide Laboratories, LLCClass IIPhenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830, NDC 42937-701-10.
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
- 2016-12-07FDA-DrugNationwide Laboratories, LLCClass IISalsalate Tablets, USP, 750 mg, packaged in a) 100 count bottles (NDC 42937-704-10); b) 500 count bottles (NDC 42937-704-18); and c) 1000 count bottles (NDC 42937-704-20); Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830.
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
- 2016-12-07FDA-DrugNationwide Laboratories, LLCClass IISalsalate Tablets, USP, 500 mg, packaged in a) 500 count bottles (NDC 42937-703-18); b) 100 count bottles (NDC 42937-703-10); and c) 1000 count bottles (NDC 42937-703-20); Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830.
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
- 2016-12-07FDA-DrugCadila Pharmaceuticals LimitedClass IIOndansetron HCI API, Bulk, Manufacturer: Cadila Pharmaceuticals, Ltd., Ankleshwar, Gujarat, India 393002
Microbial Contamination of Non-Sterile Product
- 2016-12-07FDA-DrugAscend Laboratories LLCClass IIMetformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Montvale, NJ NDC 67877-217-10
Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP
- 2016-12-07FDA-DrugBurel Pharmaceuticals IncClass IIPhenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-306-10
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
- 2016-12-07FDA-DrugBurel Pharmaceuticals IncClass IIPhenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-304-10
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
- 2016-12-07FDA-DrugBurel Pharmaceuticals IncClass IIIndiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Methylene Blue, 10 mg; Hyoscyamine Sulfate, 0.12 mg, 100 count, Rx only, Manufactured for: BUREL PHARMACEUTICALS, NDC 35573-315-10
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
- 2016-12-07FDA-DrugBurel Pharmaceuticals IncClass IIAZUPHEN MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue 10 mg, Hyoscyamine Sulfate, 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-314-10
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
- 2016-12-07FDA-DrugBurel Pharmaceuticals IncClass IIUROPHEN MB URINARY ANTISEPTIC Tablets, Each tablet contains: Methenamine 81.6 mg, Benzoic Acid 9.0 mg, Phenyl Salicylate 36 mg, Methylene Blue 10.8 mg, Hyoscyamine Sulfate 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-307-10
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
- 2016-12-07FDA-DrugBurel Pharmaceuticals IncClass IIURAMIT MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 118 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue 10 mg, Hyoscyamine Sulfate, 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-300-10
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
- 2016-12-07FDA-DrugBurel Pharmaceuticals IncClass IIUROLET MB URINARY ANTISEPTIC, ANTISPASMODIC Tablets, Each tablet contains: Methenamine 81.6 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue, 10.8 mg; Hyoscyamine Sulfate, 0.12 mg, (a) 30 count (NDC 35573-302-30) and (b) 100 count bottles (NDC 35573-302-10), Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
- 2016-12-07FDA-DrugBurel Pharmaceuticals IncClass IIHyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration contains: Hyoscyamine Sulfate 0.12 mg, Methenamine 81 mg, Methylene Blue 10.8 mg, Phenyl Salicylate 32.4 mg, Sodium Phosphate Monobasic 40.8 mg, 90 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-301-90
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
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