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Drug Recall Records

This page shows recent human drug recall alerts sourced from the FDA. It includes current and some previously imported records, but is not a complete historical archive of all past recalls. For full historical data, visit the official FDA Drug Recalls page. Always consult a healthcare professional for medical advice.

By Dosage Form:
AllTabletsCapsulesInjectables
By Recall Category:
AllContamination / SterilityLabeling / PackagingUndeclared Ingredient
Trimix Customs Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare
Date: 04/17/2013
Product: Trimix  Customs Injectable  Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Company: Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Recall Reason: Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this  compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Category: Class II
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Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, Rx only, Manufactured by Watson
Date: 03/22/2013
Product: Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60 (60 count bottles)
Company: Actavis Inc
Recall Reason: Failed Tablet/Capsule Specifications: Broken tablets
Category: Class II
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Progesterone 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA
Date: 03/20/2013
Product: Progesterone 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Company: Clinical Specialties Compounding Pharmacy
Recall Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Category: Class II
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AMBI 2CPM/15DM/5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 16 fl oz. bottle,
Date: 01/30/2013
Product: AMBI 2CPM/15DM/5PEH, Antihistamine,  Nasal Decongestant,  Fruit Candy Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0228-16.
Company: TG United, Inc.
Recall Reason: CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Category: Class II
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Japan Weight Loss Blue Capsules, 9 g (300 mg), 30 count box,
Date: 02/23/2012
Product: Japan Weight Loss Blue Capsules, 9 g (300 mg), 30 count box, Green algae lipotropic (fat dissolving) agent, OTC, Distributed by Vitaminbestbuy.com, Brewerton, NY
Company: www.vitaminbestbuy.com
Recall Reason: Marketed Without an Approved ANDA/NDA: presence of sibutramine
Category: Class I
View Details View FDA Recall Listings

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