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 →
FDA Recall
Terminated
Historical recordClass II
carBAMazepine ER, Capsule, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 66993040832
by Aidapak Services, LLC
- Reason
- Labeling:Label Mixup; carBAMazepine ER, Capsule, 200 mg may be potentially mislabeled as ACAMPROSATE CALCIUM DR, Tablet, 333 mg, NDC 00456333001, Pedigree: AD46333_1, EXP: 5/15/2014.
- Published
- January 22, 2014
- Distribution
- Repacked drugs were distributed in Arizo…
View recall →
FDA Recall
Terminated
Historical recordClass II
PHENobarbital/ HYOSCYAMINE/ ATROPINE/ SCOPOLAMINE, Tablet, 16.2 mg/0.1037 mg/0.0194 mg/0.0065 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 66213042510
by Aidapak Services, LLC
- Reason
- Labeling:Label Mixup; PHENobarbital/ HYOSCYAMINE/ ATROPINE/ SCOPOLAMINE, Tablet, 16.2 mg/0.1037 mg/0.0194 mg/0.0065 mg may be potentially mislabeled as VALSARTAN, Tablet, 160 mg, NDC 00078035934, Pedigree: W003639, EXP: 6/25/2014.
- Published
- January 22, 2014
- Distribution
- Repacked drugs were distributed in Arizo…
View recall →
FDA Recall
Terminated
Historical recordClass II
IRBESARTAN, Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65862063830
by Aidapak Services, LLC
- Reason
- Labeling:Label Mixup; IRBESARTAN, Tablet, 150 mg may be potentially mislabeled as ATROPINE SULFATE/DIPHENOXYLATE HCL, Tablet, 0.025 mg/2.5 mg, NDC 00378041501, Pedigree: W003597, EXP: 6/24/2014; CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: AD76686_7, EXP: 5/31/2014.
- Published
- January 22, 2014
- Distribution
- Repacked drugs were distributed in Arizo…
View recall →
FDA Recall
Terminated
Historical recordClass II
COLESEVELAM HCL Tablet, 625 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65597070118
by Aidapak Services, LLC
- Reason
- Labeling:Label Mixup; COLESEVELAM HCL Tablet, 625 mg may be potentially mislabeled as lamoTRIgine Tablet, 50 mg (1/2 of 100 mg), NDC 13668004701, Pedigree: AD46265_31, EXP: 5/15/2014.
- Published
- January 22, 2014
- Distribution
- Repacked drugs were distributed in Arizo…
View recall →
FDA Recall
Terminated
Historical recordClass II
guanFACINE HCl Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65162071310
by Aidapak Services, LLC
- Reason
- Labeling:Label Mixup; guanFACINE HCl Tablet, 2 mg may be potentially mislabeled as buPROPion HCl ER, Tablet, 200 mg, NDC 47335073886, Pedigree: AD21790_4, EXP: 5/1/2014; AMANTADINE HCL, Capsule, 100 mg, NDC 00781204801, Pedigree: W002997, EXP: 6/11/2014; glyBURIDE, Tablet, 1.25 mg, NDC 00093834201, Pedigree: W003677, EXP: 2/28/2014; ACYCLOVIR, Capsule, 200 mg, NDC 00093894001, Pedigree: AD60
- Published
- January 22, 2014
- Distribution
- Repacked drugs were distributed in Arizo…
View recall →
FDA Recall
Terminated
Historical recordClass II
FLECAINIDE ACETATE Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65162064110
by Aidapak Services, LLC
- Reason
- Labeling:Label Mixup; FLECAINIDE ACETATE Tablet, 50 mg may be potentially mislabeled as VITAMIN B COMPLEX W/C, Tablet, NDC 00904026013, Pedigree: AD46419_7, EXP: 5/16/2014.
- Published
- January 22, 2014
- Distribution
- Repacked drugs were distributed in Arizo…
View recall →
FDA Recall
Terminated
Historical recordClass II
PROMETHAZINE HCL, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65162052110
by Aidapak Services, LLC
- Reason
- Labeling:Label Mixup; PROMETHAZINE HCL, Tablet, 25 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: W002574, EXP: 6/3/2014.
- Published
- January 22, 2014
- Distribution
- Repacked drugs were distributed in Arizo…
View recall →
FDA Recall
Terminated
Historical recordClass II
FOLIC ACID, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65162036110
by Aidapak Services, LLC
- Reason
- Labeling:Label Mixup; FOLIC ACID, Tablet, 1 mg may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: AD32328_5, EXP: 5/9/2014; DOCUSATE CALCIUM, Capsule, 240 mg, NDC 00536375501, Pedigree: W003821, EXP: 6/27/2014; ATORVASTATIN CALCIUM, Tablet, 40 mg, NDC 00378212177, Pedigree: W003096, EXP: 6/13/2014.
- 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.
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