Drug and pharmaceutical recalls
17628 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2016-12-14FDA-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
- 2016-12-07FDA-DrugPar Pharmaceutical, Inc.Class IITravoprost Ophthalmic Solution USP, 0.004%, a) 2.5 mL and b) 5 mL bottles, Rx only, FOR USE IN THE EYES ONLY, Made in India, Distributed by: Par Pharmaceutical Cos., Inc, Spring Valley, NY 10977
Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the container
- 2016-11-30FDA-DrugWest-Ward Pharmaceuticals Corp.Class IIPhenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 0143-1455-01
Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point
- 2016-11-30FDA-DrugHospira Inc.Class IIFentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 60045, NDC 0409-4093-32
Lack of Assurance of Sterility: Complaints of broken tips on the ampules.
- 2016-11-30FDA-DrugAkorn IncClass IIDesoximetasone Ointment USP, 0.25%, a) 15 g tubes (NDC 61748-206-15 and b) 60 g tubes (NDC 61748-206-60, Marketed by Versapharm Inc., An Akorn Company, Lake Forest, IL, Manufactured by Hi-Tech, Pharmacal Co, Inc., Amityville, NY
Failed Stability Specifications; out-of specification value for homogeneity / phase separation.
- 2016-11-30FDA-DrugMylan Pharmaceuticals Inc.Class IIIDiltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01), 500-count bottle (NDC 0378-5220-05), Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA
Failed Impurities/Degradation Specifications: OOS results for known compound.
- 2016-11-30FDA-DrugPfizer Inc.Class IILEVOXYL(R) (levothyroxine sodium tablets, USP), 200 mcg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620, NDC 60793-860-01
Superpotent
- 2016-11-30FDA-DrugZydus Pharmaceuticals USA IncClass IIIBuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count bottles, Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA inc. Pennington, NJ 08534, NDC 68382-354-05
Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
- 2016-11-30FDA-DrugSun Pharmaceutical Industries, Inc.Class IIIKENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP, (0.147 mg/g), 15 g bottle, Physician Sample: Not For Sale, Rx only, RANBAXY, Jacksonville, FL 32257, UPC 3 10631 09335 8.
Failed Stability Specifications: Low Out of Specification results for alcohol content.
- 2016-11-30FDA-DrugWest-Ward Pharmaceuticals Corp.Class IIIAmoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, P.O. Box 183400, Amman 11118 - Jordan, NDC 0143-9887-01
Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.
- 2016-11-30FDA-DrugVistaPharm, Inc.Class IILactulose Solution, USP, 10 g/15 mL, 15 mL unit dose cups (NDC 66689-039-01), packaged in 15 mL x 50 unit dose cups per case (NDC 66689-039-50), Rx only, Manufactured by VistaPharm, Inc., Largo, FL 33771.
Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia.
- 2016-11-30FDA-DrugSandoz IncClass IIICeftriaxone for Injection, USP, 1 gram, 10 Single use Vials, Rx only, For IM or I.V. Use, Manufactured by: Sandoz GMbH for Hospira Worldwide, Inc., Lake Forest, Il 60045, USA, Made in Austria, NDC 0409-7332-01
Labeling: Missing Label
- 2016-11-30FDA-DrugAmerisource Health ServicesClass IIIAHP NIFEdipine Capsules, 10mg USP, 100 count carton (NDC: 68084-022-01); Individual Blister (NDC: 68084-022-11), Rx Only, Manufactured by: Actavis Elizabeth, LLC, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217
Presence of Foreign Tablets/Capsules
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