FDA Recall
Terminated
Historical recordClass II
MONTELUKAST SODIUM, CHEW Tablet, 4 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00006071131.
by Aidapak Services, LLC
- Reason
- Labeling: Label Mixup: MONTELUKAST SODIUM, CHEW Tablet, 4 mg may be potentially mislabeled as the following drug: DICYCLOMINE HCL, Tablet, 20 mg, NDC 00591079501, Pedigree: AD76639_4, EXP: 5/31/2014.
- Published
- January 29, 2014
- Distribution
- Repacked drugs were distributed in Arizo…
View recall →
FDA Recall
Terminated
Historical recordClass II
RALTEGRAVIR, Tablet, 400 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00006022761.
by Aidapak Services, LLC
- Reason
- Labeling: Label Mixup: RALTEGRAVIR, Tablet, 400 mg may be potentially mis-labeled as one of the following drugs: HYDROCORTISONE, Tablet, 5 mg, NDC00603389919, Pedigree: AD60272_13, EXP: 5/22/2014; HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 00574025001, Pedigree: W003679, EXP: 6/25/2014; HYDROCORTISONE, Tablet, 5 mg, NDC 00603389919, Pedigree: AD21790_16, EXP: 5/1/2014.
- Published
- January 29, 2014
- Distribution
- Repacked drugs were distributed in Arizo…
View recall →
FDA Recall
Terminated
Historical recordClass II
CALCIUM CARBONATE/CHOLECALCIFEROL, Tablet, 600 mg/800 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00005550924.
by Aidapak Services, LLC
- Reason
- Labeling: Label Mixup: CALCIUM CARBONATE/CHOLECALCIFEROL, Tablet, 600 mg/800 units may be potentially mis-labeled as the following drug: REPAGLINIDE, Tablet, 1 mg, NDC 00169008281, Pedigree: AD52387_1, EXP: 5/17/2014.
- Published
- January 29, 2014
- Distribution
- Repacked drugs were distributed in Arizo…
View recall →
FDA Recall
Terminated
Historical recordClass II
MYCOPHENOLATE MOFETIL, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00004026001.
by Aidapak Services, LLC
- Reason
- Labeling: Label Mixup: MYCOPHENOLATE MOFETIL, Tablet, 500 mg may be potentially mis-labeled as the following drug: MYCOPHENOLATE MOFETIL, Capsule, 250 mg, NDC 00004025901, Pedigree: AD49414_1, EXP: 5/17/2014.
- Published
- January 29, 2014
- Distribution
- Repacked drugs were distributed in Arizo…
View recall →
FDA Recall
Terminated
Historical recordClass II
ENTECAVIR, Tablet, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00003161112.
by Aidapak Services, LLC
- Reason
- Labeling: Label Mixup: ENTECAVIR, Tablet, 0.5 mg may be potentially mis-labeled as one of the following drugs: ARIPiprazole, Tablet, 2 mg, NDC 59148000613, Pedigree: AD30140_25, EXP: 5/7/2014; aMILoride HCl, Tablet, 5 mg, NDC 64980015101, Pedigree: W003686, EXP: 6/26/2014; ATOMOXETINE HCL, Capsule, 80 mg, NDC 00002325030, Pedigree: AD60272_49, EXP: 5/22/2014.
- Published
- January 29, 2014
- Distribution
- Repacked drugs were distributed in Arizo…
View recall →
FDA Recall
Terminated
Historical recordClass II
ATOMOXETINE HCL, Capsule, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002325030.
by Aidapak Services, LLC
- Reason
- Labeling: Label Mixup: ATOMOXETINE HCL, Capsule, 80 mg may be potentially mis-labeled as one of the following drugs: ATOMOXETINE HCL, Capsule, 18 mg, NDC 00002323830, Pedigree: AD30140_16, EXP: 5/7/2014; PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet, 0 mg, NDC 00904531360, Pedigree: W003706, EXP: 6/25/2014; RANOLAZINE ER, Tablet, 500 mg, NDC 61958100301, Pedigree: AD60272_40, EXP: 5/22/2014; PRO
- Published
- January 29, 2014
- Distribution
- Repacked drugs were distributed in Arizo…
View recall →
FDA Recall
Terminated
Historical recordClass II
ATOMOXETINE HCL, Capsule, 18 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002323830.
by Aidapak Services, LLC
- Reason
- Labeling: Label Mixup: ATOMOXETINE HCL, Capsule, 18 mg, may be potentially mis-labeled as the following drug: LOVASTATIN, Tablet, 20 mg, NDC 00185007201, Pedigree: AD28369_1, EXP: 5/7/2014.
- Published
- January 29, 2014
- Distribution
- Repacked drugs were distributed in Arizo…
View recall →
FDA Recall
Terminated
Historical recordClass II
DULoxetine HCl DR, Capsule, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002323560.
by Aidapak Services, LLC
- Reason
- Labeling: Label Mixup: DULoxetine HCl DR, Capsule, 20 mg, may be potentially mis-labeled with one of the following drugs: ENTECAVIR, Tablet, 0.5 mg, NDC 00003161112, Pedigree: AD30140_28, EXP: 5/7/2014; CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD54587_1, EXP: 5/21/2014; FLUoxetine HCl, Capsule, 10 mg , NDC 16714035103, Pedigree: AD70585_13, EXP: 5/29/2014; CHOLECALCIFEROL
- Published
- January 29, 2014
- Distribution
- Repacked drugs were distributed in Arizo…
View recall →
FDA Recall
Terminated
Historical recordClass II
ATOMOXETINE HCL, Capsule, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002322930.
by Aidapak Services, LLC
- Reason
- Labeling: Label Mixup: ATOMOXETINE HCL, Capsule, 40 mg may be potentially mis-labeled as OLANZAPINE, Tablet, 7.5 mg, NDC 60505311203, Pedigree: AD21790_76, EXP: 5/1/2014; ARIPiprazole, Tablet, 2 mg, NDC 59148000613, Pedigree: AD46265_19, EXP: 5/15/2014; OLANZapine, Tablet, 7.5 mg, NDC 55111016530, Pedigree: AD60272_79, EXP: 5/22/2014; OLANZapine, Tablet, 7.5 mg, NDC 55111016530, Pedigree: AD73
- Published
- January 29, 2014
- Distribution
- Repacked drugs were distributed in Arizo…
View recall →
FDA Recall
Terminated
Historical recordClass I
Cubicin (daptomycin for injection), 500 mg lyophilized powder, 10 mL single-use vials, Rx only, Manufactured for Cubist Pharmaceuticals, Inc., Lexington, MA
by Cubist Pharmaceuticals, Inc.
- Reason
- Presence of Particulate Matter; Glass particulates observed in vials
- Published
- January 29, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Theraflu Cold and Flu (acetaminophen 325 mg, phenylephrine hydrochloride 10 mg and pheniramine maleate 20 mg) powder packets, Forest Berries flavor, 10-count packets per box, UPC 4 607045 191760. (Russian product and Former Soviet Union product)
by Novartis Consumer Health
- Reason
- Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
- Published
- January 29, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
NeoCitran Extra Strength Non-Drowsy Cold & Sinus (acetaminophen 650 mg and phenylephrine hydrochloride 10 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 05703 3. Also packaged under foreign label: Theraflu Daytime Severe Cold powder packets, Natural Lemon flavor, 6-count packets per carton, Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-7116-06, UPC 8 806536 01402 1 (Korea Product)
by Novartis Consumer Health
- Reason
- Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
- Published
- January 29, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
NeoCitran DM Cough & Cold (dextromethorphan hydrobromide 30 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 05503 9.
by Novartis Consumer Health
- Reason
- Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
- Published
- January 29, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
NeoCitran (acetaminophen 1000 mg, pseudoephedrine hydrochloride 60 mg, dextromethorphan hydrobromide 30 mg, chlorpheniramine maleate 4 mg) powder packets, Natural Source Cherry flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, labeled as a) NeoCitran Ultra Strength Total Flu 7 Symptom Relief (UPC 0 58478 47365 9) and b) NeoCitran Extra Strength Sore Throat & Cough (UPC 0 58478 47365 9).
by Novartis Consumer Health
- Reason
- Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
- Published
- January 29, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Theraflu Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine hydrochloride 10 mg) powder packets, Honey Lemon Infused with Chamomille & White Tea flavors, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0043-6256-06, UPC 3 0043-6256-06. Also packaged under foreign label: NeoCitran Extra Strength Sugar Free Total 7 Symptom Relief (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, diphenhydramine hydrochloride 25 mg, Soothing Honey Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., UPC 0 58478 10594 9.
by Novartis Consumer Health
- Reason
- Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
- Published
- January 29, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Theraflu Flu & Chest Congestion (acetaminophen 1000 mg and guaifenesin 400 mg) powder packets, Natural Citrus flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0043-0483-06, UPC 3 0043-0483-06 1.
by Novartis Consumer Health
- Reason
- Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
- Published
- January 29, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Theraflu Sugar-Free Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine hydrochloride 10 mg) powder packets, Honey Lemon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-6318-06, UPC 3 0043-6318-06 0.
by Novartis Consumer Health
- Reason
- Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
- Published
- January 29, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Theraflu MAX-D Severe Cold & Flu (acetaminophen 1000 mg, dextromethorphan HBr 30 mg, guaifenesin 400 mg, pseudoephedrine HCl 60 mg) powder packets, Natural Citrus flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-6427-06, UPC 3 0067-6427-06 5. Also packaged under foreign label: NeoCitran Extra Strength Total 7 Symptom Relief Plus Mucous Relief powder packets, Soothing Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 10701 1.
by Novartis Consumer Health
- Reason
- Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
- Published
- January 29, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Theraflu Multi-Symptom Severe Cold (acetaminophen 500 mg, dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Green Tea & Honey Lemon flavors, packaged in a) 6-count packets per carton (NDC 0067-6426-06, UPC 3 0067-6426-06 8) and b) 1-count packet per card (NDC 0067-6426-01, UPC 3 0067-6426-01 3), Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622.
by Novartis Consumer Health
- Reason
- Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
- Published
- January 29, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Theraflu (acetaminophen 325 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Natural Lemon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, labeled as a) Theraflu Sinus & Cold (NDC 0067-6319-06, UPC 3 0043-6319-06 7) and b) Theraflu Cold & Sore Throat (NDC 0067-6716-06, UPC 3 0043-0467-16 0). Also packaged under foreign labels: NeoCitran Cold & Flu powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 05009 6; and Theraflu Exthegran powder packets, lemon flavor, packaged in a) 6-count packets per carton (UPC 7 501124 812904) and b) 10-count packets per carton (UPC 7 501124 814588), Distributed by Novartis Farmaceutica S.A. De C.V., Mexico
by Novartis Consumer Health
- Reason
- Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
- Published
- January 29, 2014
- Distribution
- Nationwide
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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