🍔 Food 💊 Drugs 🏥 Medical Devices
ATOMOXETINE HCL, Capsule, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002325030. Class II

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

Aidapak Services, LLC 20130702 Terminated
Distributed: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
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ATOMOXETINE HCL, Capsule, 18 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002323830. Class II

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.

Aidapak Services, LLC 20130702 Terminated
Distributed: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
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DULoxetine HCl DR, Capsule, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002323560. Class II

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

Aidapak Services, LLC 20130702 Terminated
Distributed: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
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ATOMOXETINE HCL, Capsule, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002322930. Class II

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

Aidapak Services, LLC 20130702 Terminated
Distributed: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
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Cubicin (daptomycin for injection), 500 mg lyophilized powder, 10 mL single-use vials, Rx only, Manufactured for Cubist Pharmaceuticals, Inc., Lexington, MA Class I

Reason: Presence of Particulate Matter; Glass particulates observed in vials

Cubist Pharmaceuticals, Inc. 20130829 Terminated
Distributed: Nationwide
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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) Class II

Reason: Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Novartis Consumer Health 20130618 Terminated
Distributed: Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.
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Theraflu Exte (dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 20 mg, chlorpheniramine maleate 10 mg) powder packets, lemon flavor, packaged in a) 6-count packets per carton (UPC 7 501124 812881) and b) 10-count packets per carton (UPC 7 501124 814595), Distributed by Novartis Farmaceutica, S.A., DE C.V., Mexico. Class II

Reason: Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Novartis Consumer Health 20130618 Terminated
Distributed: Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.
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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) Class II

Reason: Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Novartis Consumer Health 20130618 Terminated
Distributed: Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.
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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. Class II

Reason: Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Novartis Consumer Health 20130618 Terminated
Distributed: Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.
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NeoCitran Extra Strength Cold & Flu (acetaminophen 650 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 05103 1. Also packaged under foreign labels: Theraflu Extra Cold and Flu powder packets, Lemon flavor, 10-count packets per box, UPC 4 607045 191395 (Russia and Former Soviet Union product); Theraflu Nighttime Severe Cold powder packets, Natural Lemon flavor, 6-count packets per carton, Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, UPC 8 806536 013925 (Korea product); Class II

Reason: Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Novartis Consumer Health 20130618 Terminated
Distributed: Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.
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