FDA Recall
Terminated
Historical recordClass II
HydrOXYzine HCI Tablets USP 10 mg, 100 count bottles, Rx only. Mfd by KVK-TECH, INC, Newtown, PA 18940. NDC #10702-010-01.
by KVK-Tech, Inc.
- Reason
- Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
- Published
- January 29, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TRI-BUFFERED ASPIRIN, Tablet, 325 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904201559.
by Aidapak Services, LLC
- Reason
- 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.
- Published
- January 29, 2014
- Distribution
- Repacked drugs were distributed in Arizo…
View recall →
FDA Recall
Terminated
Historical recordClass II
NIACIN TR, Capsule, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00904062960.
by Aidapak Services, LLC
- Reason
- Labeling: Label Mixup: NIACIN TR, Capsule, 250 mg may have potentially been mislabeled as the following drug: METHYLERGONOVINE MALEATE, Tablet, 0.2 mg, NDC 43386014028, Pedigree: W003477, EXP: 6/20/2014.
- Published
- January 29, 2014
- Distribution
- Repacked drugs were distributed in Arizo…
View recall →
FDA Recall
Terminated
Historical recordClass II
AMANTADINE HCL, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00832011100.
by Aidapak Services, LLC
- Reason
- Labeling: Label Mixup: AMANTADINE HCL, Tablet, 100 mg may have potentially been mislabeled as one of the following drugs: MAGNESIUM CHLORIDE, Tablet, 64 mg, NDC 68585000575, Pedigree: AD52993_4, EXP: 5/17/2014; QUEtiapine FUMARATE, Tablet, 25 mg, NDC 65862048901, Pedigree: AD49582_22, EXP: 4/30/2014.
- Published
- January 29, 2014
- Distribution
- Repacked drugs were distributed in Arizo…
View recall →
FDA Recall
Terminated
Historical recordClass II
TACROLIMUS, Capsule, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781210301.
by Aidapak Services, LLC
- Reason
- Labeling: Label Mixup: TACROLIMUS, Capsule, 1 mg may have potentially been mislabeled as one of the following drugs: BISOPROLOL FUMARATE, Tablet, 5 mg, NDC 29300012601, Pedigree: AD34934_7, EXP: 5/10/2014; SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: AD56917_4, EXP: 5/21/2014; SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: AD73627_11, EXP: 5/30/2014; ATOMOXE
- Published
- January 29, 2014
- Distribution
- Repacked drugs were distributed in Arizo…
View recall →
FDA Recall
Terminated
Historical recordClass II
AMANTADINE HCL, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781204801.
by Aidapak Services, LLC
- Reason
- 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
- Published
- January 29, 2014
- Distribution
- Repacked drugs were distributed in Arizo…
View recall →
FDA Recall
Terminated
Historical recordClass III
Zithromax (azithromycin for injection), 500 mg/vial, Sterile, Rx Only, For I.V. infusion only, No latex, No preservative, Made in Ireland, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, NDC 0069-3150-84
by Pfizer Inc.
- Reason
- Failed Impurities/Degradation Specifications: Pfizer is recalling certain lots due to out of specification results for azithromycin N-oxide degradant.
- Published
- January 22, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Excedrin, Sinus Headache, Acetaminophen 325mg, Phenylephrine HCL 5mg , 2 caplets. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2062-02.
by Novartis Consumer Health
- Reason
- Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing
- Published
- January 22, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Theraflu Warming Relief, Multi-Symptom Cold, Acetaminophen 325mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in a) 8 coated caplets (NDC 0067-6438-08) b) 24 coated caplets (NDC 0067-6438-24), Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622.
by Novartis Consumer Health
- Reason
- Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing
- Published
- January 22, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Maximum Strength Comtrex ,Severe Cold & Sinus Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Phenylephrine HCL 5mg, packaged in 12 coated caplets daytime formula and 12 coated caplets nighttime formula. Novartis, distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2081-24
by Novartis Consumer Health
- Reason
- Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
- Published
- January 22, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Maximum Strength Comtrex , Day/Night Flu Therapy , Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in 12 coated caplets daytime formula and 12 coated caplets nighttime formula. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2084-24.
by Novartis Consumer Health
- Reason
- Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
- Published
- January 22, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Maximum Strength Comtrex Nighttime Cold & Cough, Acetaminophen 325mg ,Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg,Phenylephrine HCL 5mg, packaged in 24 coated caplets nighttime formula *includes antihistamine, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 075054-0622, NDC 0067-2081-24.
by Novartis Consumer Health
- Reason
- Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
- Published
- January 22, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PEGASPARGASE ONCASPAR Injection, 3750 International Units Per 5mL vial, Rx ONLY, sigma-tau PHARMACEUTICALS INC, 9841 Washingtonian Blvd, Gaithersburg, MD 20878 NDC 54482-301-01
by Sigma-Tau Pharmaceuticals, Inc.
- Reason
- Lack of Assurance of Sterility: Sigma-Tau PharmaSource, Inc. is conducting a voluntary recall of five lots of Oncaspar Injection, because of a crack under the crimp seal which caused a leak.
- Published
- January 22, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
HYOSCYAMINE SULFATE SL Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 76439030910
by Aidapak Services, LLC
- Reason
- Labeling:Label Mixup; HYOSCYAMINE SULFATE SL Tablet, 0.125 mg may be potentially mislabeled as azaTHIOprine, Tablet, 50 mg, NDC 00054408425, Pedigree: AD56832_1, EXP: 5/21/2014; CHOLECALCIFEROL, Tablet, 1000 units, NDC 00904582460, Pedigree: W003464, EXP: 6/20/2014.
- Published
- January 22, 2014
- Distribution
- Repacked drugs were distributed in Arizo…
View recall →
FDA Recall
Terminated
Historical recordClass II
VERAPAMIL HCL ER, Tablet, 240 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68462026001
by Aidapak Services, LLC
- Reason
- Labeling:Label Mixup; VERAPAMIL HCL ER, Tablet, 240 mg may be potentially mislabeled as TRIFLUOPERAZINE HCL, Tablet, 1 mg, NDC 00781103001, Pedigree: AD52778_91, EXP: 5/21/2014.
- Published
- January 22, 2014
- Distribution
- Repacked drugs were distributed in Arizo…
View recall →
FDA Recall
Terminated
Historical recordClass II
FLUCONAZOLE, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68462010230
by Aidapak Services, LLC
- Reason
- Labeling:Label Mixup; FLUCONAZOLE, Tablet, 100 mg may be potentially mislabeled as PRENATAL MULTIVITAMIN/ MULTIMINERAL, Tablet, NDC 51991056601, Pedigree: W003086, EXP: 6/12/2014.
- Published
- January 22, 2014
- Distribution
- Repacked drugs were distributed in Arizo…
View recall →
FDA Recall
Terminated
Historical recordClass II
amLODIPine BESYLATE, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68382012316
by Aidapak Services, LLC
- Reason
- Labeling:Label Mixup; amLODIPine BESYLATE, Tablet, 10 mg may be potentially mislabeled as FINASTERIDE, Tablet, 5 mg, NDC 16714052201, Pedigree: AD62846_1, EXP: 2/28/2014.
- Published
- January 22, 2014
- Distribution
- Repacked drugs were distributed in Arizo…
View recall →
FDA Recall
Terminated
Historical recordClass II
RAMIPRIL, Capsule, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68180058901
by Aidapak Services, LLC
- Reason
- Labeling:Label Mixup; RAMIPRIL, Capsule, 2.5 mg, Rx only may be potentially mislabeled as PROPAFENONE HCL, Tablet, 150 mg, NDC 00591058201, Pedigree: AD54549_13, EXP: 5/20/2014; CALCIUM POLYCARBOPHIL, Tablet, 625 mg, NDC 00536430611, Pedigree: AD73592_11, EXP: 5/31/2014.
- Published
- January 22, 2014
- Distribution
- Repacked drugs were distributed in Arizo…
View recall →
FDA Recall
Terminated
Historical recordClass II
IBUPROFEN, Tablet, 400 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 67877029401
by Aidapak Services, LLC
- Reason
- Labeling:Label Mixup; IBUPROFEN, Tablet, 400 mg may be potentially mislabeled as ASPIRIN, Tablet, 325 mg, NDC 00536330501, Pedigree: W002573, EXP: 6/3/2014.
- Published
- January 22, 2014
- Distribution
- Repacked drugs were distributed in Arizo…
View recall →
FDA Recall
Terminated
Historical recordClass II
buPROPion HCl ER (XL), Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 67767014130
by Aidapak Services, LLC
- Reason
- Labeling:Label Mixup; buPROPion HCl ER (XL), Tablet, 150 mg may be potentially mislabeled as MESALAMINE CR, Capsule, 250 mg, NDC 54092018981, Pedigree: AD52412_1, EXP: 5/17/2014.
- Published
- January 22, 2014
- Distribution
- Repacked drugs were distributed in Arizo…
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
Read the full medical disclaimer.