Drug and pharmaceutical recalls
17747 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2014-02-05FDA-DrugSS Wholesale Inc. dba Jobbers WholesaleClass IeXtenZone capsules, 1 capsule per blister pack, Distributed by: P.M.C. Company, Buena Park, CA 90621, UPC 6 89076 49126 6.
Marketed Without An Approved NDA/ANDA: FDA analysis found eXtenZone which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug. Dapoxetine is an active ingredient not approved b
- 2014-02-05FDA-DrugSS Wholesale Inc. dba Jobbers WholesaleClass IMaXtremeZEN capsules, 1 capsule per blister pack, Distributed by: P&A Enterprise, Buena Park, CA 90621, UPC 6 10079 52468 2.
Marketed Without An Approved NDA/ANDA: FDA analysis found MaXtremeZEN which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug. Dapoxetine is an active ingredient not approved
- 2014-02-05FDA-DrugSS Wholesale Inc. dba Jobbers WholesaleClass IRhino 5 capsules(Spanish & English Labeling), 1 capsule per blister pack, Distributed by P&A Enterprise, Buena Park, CA 90621, English UPC 6 10708 10730 9, Spanish UPC 6 10708 10729 3.
Marketed Without An Approved NDA/ANDA: FDA analysis found Rhino 5 which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug. Dapoxetine is an active ingredient not approved by
- 2014-02-05FDA-DrugFougera Pharmaceuticals Inc.Class IIIKETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0099-30, UPC 3 0168-0099-30 9.
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
- 2014-02-05FDA-DrugActavis IncClass IIIBuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-3331-30), b) 90 count bottle (NDC 0591-3331-19), c) 500 count bottle (NDC 0591-3331-05), Manufactactred By: Watson Laboratories, Inc. Corona, CA 92880
Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.
- 2014-02-05FDA-DrugWockhardt Usa Inc.Class IIPantaprazole Sodium Delayed Release Tablets , USP 40 mg, 1000 tablets bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd Parsippany, NJ 07054 USA. NDC: 64679-0434-02.
Failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit specifications.
- 2014-02-05FDA-DrugThe Mentholatum Co.Class IIROHTO Redness Relief, Cool, Redness Reliever, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01074 9, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam.
Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.
- 2014-02-05FDA-DrugThe Mentholatum Co.Class IIROHTO Cooling Eye Drops, Itch Relief, Soothes Itch & Burn, relief, Astringent, Lubricant, Redness Reliever Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01099 2, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam.
Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.
- 2014-02-05FDA-DrugThe Mentholatum Co.Class IIROHTO Dry Eye, hydra, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01096 1, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam.
Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.
- 2014-02-05FDA-DrugThe Mentholatum Co.Class IIROHTO Redness Relief, ice, Redness Reliever, Lubricant, Astringent Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01086 2, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam.
Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.
- 2014-02-05FDA-DrugThe Mentholatum Co.Class IIROHTO Redness Relief, arctic, Redness Reliever, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 10909 2, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam.
Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.
- 2014-02-05FDA-DrugHospira Inc.Class IIHeparin Sodium 2000 USP Heparin Units per 1000 mL (2 USP Heparin Units/mL) in 0.9% Sodium Chloride Injection, Rx only. Hospira, Lake Forest, IL 60045. NDC 0409-7620-59.
Lack of Assurance of Sterility; potential leakage from administrative port.
- 2014-02-05FDA-DrugHospira Inc.Class IIAminosyn 3.5% M Sulfite-Free, A Crystalline Amino Acid Solution* with Maintenance Electrolytes with Phosphorus, 1000 mL bag, Rx only. Hospira Inc, Lake Forest, IL, 60045. NDC: 0409-4196-05
Lack of Assurance of Sterility; potential leakage from administrative port.
- 2014-01-29FDA-DrugAidapak Services, LLCClass IIMETHAZOLAMIDE, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781107101.
Labeling: Label Mixup: METHAZOLAMIDE, Tablet, 50 mg may have potentially been mislabeled as the following drug: BUPRENORPHINE HCL SL, Tablet, 2 mg, NDC 00054017613, Pedigree: AD39573_1, EXP: 5/13/2014.
- 2014-01-29FDA-DrugAidapak Services, LLCClass IIPERPHENAZINE, Tablet, 16 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781104901.
Labeling: Label Mixup: PERPHENAZINE, Tablet, 16 mg may have potentially been mislabeled as one of the following drugs: LITHIUM CARBONATE ER, Tablet, 450 mg, NDC 00054002025, Pedigree: AD21790_28, EXP: 5/1/2014; LITHIUM CARBONATE ER, Tablet, 450 mg, NDC 00054002025, Pedigree: W002730, EXP: 6/6/2014; RALTEGRAVIR, Tablet, 400 mg, NDC 00006022761, Pedigree: W003680, EXP: 6/25/2014; VENLAFAXINE HCL
- 2014-01-29FDA-DrugAidapak Services, LLCClass IITRIFLUOPERAZINE HCL, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781103001.
Labeling: Label Mixup: TRIFLUOPERAZINE HCL, Tablet, 1 mg may have potentially been mislabeled as the following drug: TERBUTALINE SULFATE, Tablet, 2.5 mg, NDC 00115261101, Pedigree: AD52778_88, EXP: 5/21/2014.
- 2014-01-29FDA-DrugAidapak Services, LLCClass IICHOLECALCIFEROL, Tablet, 5000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00761017840.
Labeling: Label Mixup: CHOLECALCIFEROL, Tablet, 5000 units may have potentially been mislabeled as one of the following drugs: LACTOBACILLUS ACIDOPHILUS, Capsule, 0 mg, NDC 54629011101, Pedigree: AD65311_7, EXP: 5/24/2014; QUINAPRIL HCL, Tablet, 20 mg, NDC 68180055809, Pedigree: W003556, EXP: 6/24/2014; POTASSIUM ACID PHOSPHATE, Tablet, 500 mg, NDC 00486111101, Pedigree: AD52778_34, EXP: 5/20/2
- 2014-01-29FDA-DrugAidapak Services, LLCClass IIPERPHENAZINE, Tablet, 8 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00630506221.
Labeling: Label Mixup: PERPHENAZINE, Tablet, 8 mg may have potentially been mislabeled as the following drug: NIFEdipine, Capsule, 10 mg, NDC 59762100401, Pedigree: AD52778_55, EXP: 5/20/2014.
- 2014-01-29FDA-DrugAidapak Services, LLCClass IIsulfaSALAzine, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603580121.
Labeling: Label Mixup: sulfaSALAzine, Tablet, 500 mg may have potentially been mislabeled as one of the following drugs: FLUCONAZOLE, Tablet, 200 mg, NDC 00172541360, Pedigree: AD65475_16, EXP: 5/28/2014; PHENYTOIN SODIUM ER, Capsule, 30 mg, NDC 00071374066, Pedigree: W003331, EXP: 6/19/2014.
- 2014-01-29FDA-DrugAidapak Services, LLCClass IIPROPRANOLOL HCL, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603548221.
Labeling: Label Mixup: PROPRANOLOL HCL, Tablet, 10 mg may have potentially been mislabeled as one of the following drugs: LORazepam, Tablet, 0.25 mg (1/2 of 0.5 mg), NDC 00591024001, Pedigree: AD60243_1, EXP: 5/22/2014; PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree: W003068, EXP: 6/12/2014.
- 2014-01-29FDA-DrugAidapak Services, LLCClass IIPHENobarbital, Tablet, 97.2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603516832.
Labeling: Label Mixup: PHENobarbital, Tablet, 97.2 mg may have potentially been mislabeled as the following drug: EFAVIRENZ, Capsule, 200 mg, NDC 00056047492, Pedigree: AD46312_31, EXP: 5/16/2014.
- 2014-01-29FDA-DrugAidapak Services, LLCClass IIPHENobarbital, Tablet, 97.2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603516821.
Labeling: Label Mixup: PHENobarbital, Tablet, 97.2 mg may have potentially been mislabeled as the following drug: PHENobarbital, Tablet, 64.8 mg, NDC 00603516721, Pedigree: AD73518_7, EXP: 5/31/2014.
- 2014-01-29FDA-DrugAidapak Services, LLCClass IIPHENobarbital, Tablet, 64.8 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603516721.
Labeling: Label Mixup: PHENobarbital, Tablet, 64.8 mg may have potentially been mislabeled as the following drug: PREGABALIN, Capsule, 200 mg, NDC 00071101768, Pedigree: AD73518_4, EXP: 5/31/2014.
- 2014-01-29FDA-DrugAidapak Services, LLCClass IIPERPHENAZINE, Tablet, 16 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603506321.
Labeling: Label Mixup: PERPHENAZINE, Tablet, 16 mg may have potentially been mislabeled as one of the following drugs: MELATONIN, Tablet, 1 mg, NDC 47469000466, Pedigree: AD46257_19, EXP: 5/15/2014; LITHIUM CARBONATE ER, Tablet, 450 mg, NDC 00054002025, Pedigree: AD60272_25, EXP: 5/22/2014; MONTELUKAST SODIUM, CHEW Tablet, 4 mg, NDC 00006071131, Pedigree: AD76639_11, EXP: 5/31/2014.
- 2014-01-29FDA-DrugAidapak Services, LLCClass IIOXYBUTYNIN CHLORIDE, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603497521.
Labeling: Label Mixup: OXYBUTYNIN CHLORIDE, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: FLECAINIDE ACETATE, Tablet, 100 mg, NDC 00054001125, Pedigree: AD56847_4, EXP: 5/21/2014; SODIUM CHLORIDE, Tablet, 1 gm, NDC 00223176001, Pedigree: W003792, EXP: 6/27/2014; VARENICLINE, Tablet, 0.5 mg, NDC 00069046856, Pedigree: AD22616_1, EXP: 5/2/2014.
- 2014-01-29FDA-DrugAidapak Services, LLCClass IIOXYBUTYNIN CHLORIDE, Tablet, 2.5 mg (1/2 of 5 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 00603497521
Labeling: Label Mixup: OXYBUTYNIN CHLORIDE, Tablet, 2.5 mg (1/2 of 5 mg) may have potentially been mislabeled as the following drug: PIMOZIDE, Tablet, 1 mg (1/2 of 2 mg), NDC 57844018701, Pedigree: AD73525_61, EXP: 5/30/2014.
- 2014-01-29FDA-DrugAidapak Services, LLCClass IIMODAFINIL, Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603466216.
Labeling: Label Mixup: MODAFINIL, Tablet, 200 mg may have potentially been mislabeled as one of the following drugs: OMEGA-3-ACID ETHYL ESTERS, Capsule, 1000 mg, NDC 00173078302, Pedigree: W003692, EXP: 6/26/2014.
- 2014-01-29FDA-DrugAidapak Services, LLCClass IImethylPREDNISolone, Tablet, 4 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603459321.
Labeling: Label Mixup: methylPREDNISolone, Tablet, 4 mg may have potentially been mislabeled as the following drug: OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/110 mg, NDC 11523726503, Pedigree: AD42584_15, EXP: 5/14/2014.
- 2014-01-29FDA-DrugAidapak Services, LLCClass IIHYDROCORTISONE, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603389919.
Labeling: Label Mixup: HYDROCORTISONE, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: carBAMazepine ER, Tablet, 200 mg, NDC 51672412401, Pedigree: AD60272_7, EXP: 5/22/2014; guanFACINE HCl, Tablet, 1 mg, NDC 00591044401, Pedigree: W002728, EXP: 4/30/2014; glyBURIDE, Tablet, 1.25 mg, NDC 00093834201, Pedigree: AD21790_10, EXP: 2/28/2014; ACARBOSE, Tablet, 25 mg
- 2014-01-29FDA-DrugAidapak Services, LLCClass IIGLYCOPYRROLATE, Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603318121.
Labeling: Label Mixup: GLYCOPYRROLATE, Tablet, 2 mg may have potentially been mislabeled as one of the following drugs: PARICALCITOL, Capsule, 1 mcg, NDC 00074431730, Pedigree: W002667, EXP: 6/5/2014; guaiFENesin ER, Tablet, 600 mg, NDC 63824000850, Pedigree: W003244, EXP: 6/17/2014; LACTOBACILLUS, Tablet, 0, NDC 64980012950, Pedigree: AD22865_1, EXP: 5/2/2014.
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