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
Drugs Recalls
Prescription and over-the-counter medications
FLUCONAZOLE, Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00172541360.
Aidapak Services
Labeling: Label Mixup: FLUCONAZOLE, Tablet, 200 mg may have potentially been mislabeled as one of the following drugs: VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree: AD65475_10, EXP: 5/28/2014; FLUCONAZOLE, Tablet, 100 mg, NDC 68462010230, Pedigree: W003064, EXP: 6/12/2014.
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
PERPHENAZINE, Tablet, 8 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00630506221.
Aidapak Services
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.
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
SILDENAFIL CITRATE, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00069420030.
Aidapak Services
Labeling: Label Mixup: SILDENAFIL CITRATE, Tablet, 25 mg may have potentially been mislabeled as the following drug: PHENobarbital/ HYOSCYAMINE/ ATROPINE/ SCOPOLAMINE, Tablet, 16.2 mg/0.1037 mg/0.0194 mg/0.0065 mg, NDC 66213042510, Pedigree: W003640, EXP: 6/25/2014.
FLECAINIDE ACETATE, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054001125.
Aidapak Services
Labeling: Label Mixup: FLECAINIDE ACETATE, Tablet, 100 mg may be potentially mislabeled as the following drug: COLESTIPOL HCL MICRONIZED, Tablet, 1 g, NDC 59762045001, Pedigree: AD56847_1, EXP: 5/21/2014.
glyBURIDE MICRONIZED, Tablet, 3 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093803501.
Aidapak Services
Labeling: Label Mixup: glyBURIDE MICRONIZED, Tablet, 3 mg may have potentially been mislabeled as the following drug: DIGOXIN, Tablet, 0.125 mg, NDC 00115981101, Pedigree: W003154, EXP: 6/13/2014.
CYANOCOBALAMIN, Tablet, 500 mcg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536355101.
Aidapak Services
Labeling: Label Mixup:CYANOCOBALAMIN, Tablet, 500 mcg was mislabled as SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: W002859, EXP: 6/7/2014. and may have potentially been mislabeled as one of the following drugs: VITAMIN B COMPLEX W/C, Tablet, 0, NDC 00536730001, Pedigree: AD52993_7, EXP: 5/20/2014; CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00536355601, Pedigree: AD30180_22, EXP:
LEVOTHYROXINE SODIUM, Tablet, 137 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00527163801.
Aidapak Services
Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 137 mcg may have potentially been mislabeled as the following drug: ISONIAZID, Tablet, 300 mg, NDC 00555007102, Pedigree: AD60272_70, EXP: 5/22/2014.
TRI-BUFFERED ASPIRIN, Tablet, 325 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904201559.
Aidapak Services
Labeling: Label Mixup: TRI-BUFFERED ASPIRIN, Tablet, 325 mg may have potentially been mislabeled as the following drug: ISOMETHEPTENE MUCATE/ DICHLORALPHENAZONE/APAP, Capsule, 65 mg/100 mg/325 mg, NDC 44183044001, Pedigree: W003596, EXP: 5/31/2014.
DRONEDARONE HCL, Tablet, 400 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00024414260.
Aidapak Services
Labeling: Label Mixup: DRONEDARONE HCL, Tablet, 400 mg may be potentially as the following drug: METHYLERGONOVINE MALEATE, Tablet, 0.2 mg, NDC 43386014028, Pedigree: AD52778_40, EXP: 5/20/2014.
NABUMETONE, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00185014501.
Aidapak Services
Labeling: Label Mixup: NABUMETONE, Tablet, 500 mg may have potentially been mislabeled as the following drug: guaiFENesin ER, Tablet, 600 mg, NDC 63824000834, Pedigree: AD46429_1, EXP: 5/15/2014.
ACETAMINOPHEN, CHEW Tablet, 80 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536323307.
Aidapak Services
Labeling: Label Mixup: ACETAMINOPHEN, CHEW Tablet, 80 mg may have potentially been mislabeled as one of the following drugs: BENAZEPRIL HCL, Tablet, 40 mg, NDC 65162075410, Pedigree: AD49423_1, EXP: 5/16/2014; ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: W003101, EXP: 6/13/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: AD30028_1, EXP: 5/8/2014; TACROLIMUS,
PHENYTOIN SODIUM ER, Capsule, 30 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00071374066.
Aidapak Services
Labeling: Label Mixup: PHENYTOIN SODIUM ER, Capsule, 30 mg may have potentially been mislabeled as the following drug: LITHIUM CARBONATE ER, Tablet, 450 mg, NDC 00054002025, Pedigree: W003327, EXP: 6/19/2014.
MINOCYCLINE HCL, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591569550.
Aidapak Services
Labeling: Label Mixup: MINOCYCLINE HCL, Capsule, 100 mg may have potentially been mislabeled as the following drug: PROGESTERONE, Capsule, 100 mg, NDC 00591396401, Pedigree: AD73611_4, EXP: 5/30/2014.
SOTALOL HCL, Tablet, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093106101.
Aidapak Services
Labeling: Label Mixup: SOTALOL HCL, Tablet, 80 mg may have potentially been mislabeled as one of the following drugs: DILTIAZEM HCL, Tablet, 120 mg, NDC 00093032101, Pedigree: AD30197_1, EXP: 5/9/2014; PROPRANOLOL HCL ER, Capsule, 60 mg, NDC 00228277811, Pedigree: AD54605_4, EXP: 5/20/2014.
LACTOBACILLUS ACIDOPHILUS, Tablet, 35 MILLION, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536718101.
Aidapak Services
Labeling: Label Mixup: LACTOBACILLUS ACIDOPHILUS, Tablet, 35 MILLION may have potentially been mislabeled as the following drug: REPAGLINIDE, Tablet, 1 mg, NDC 00169008281, Pedigree: W003924, EXP: 6/28/2014.
AMANTADINE HCL, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781204801.
Aidapak Services
Labeling: Label Mixup: AMANTADINE HCL, Capsule, 100 mg may have potentially been mislabeled as one of the following drugs: ACARBOSE, Tablet, 25 mg, NDC 00054014025, Pedigree: W002725, EXP: 6/6/2014; clomiPRAMINE HCl, Capsule, 50 mg, NDC 51672401205, Pedigree: W002998, EXP: 6/11/2014; ASPIRIN EC DR, Tablet, 81 mg, NDC 49348098015, Pedigree: W003672, EXP: 2/28/2014; NIACIN TR, Capsule, 500 mg, N
MINOXIDIL, Tablet, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591564201.
Aidapak Services
Labeling: Label Mixup:MINOXIDIL, Tablet, 2.5 mg may have potentially been mislabeled as the following drug: methylPREDNISolone, Tablet, 4 mg, NDC 00781502201, Pedigree: AD52778_43, EXP: 5/20/2014.