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Drug recalls

Enforcement reports from the FDA's weekly recall database. Recalls are classified by the health hazard the defect presents: Class I where exposure is reasonably likely to cause serious harm or death, Class II where it may cause temporary or reversible harm, and Class III where it is unlikely to cause harm.

17,975 records · source: openFDA Enforcement

All classes 17,975 Class II 14,511 Class I 1,747 Class III 1,715 Not Yet Classified 2
Most recent recall enforcement reports first.
Class Reported Product Reason Firm Status
Class II February 6, 2013 Temodar (temozolomide) Capsule, 20 mg per capsule, 5 capsules per package, For Oral… Failed Impurities/Degradation Specifications: The recall is being initiated due to an out-of-specification result in… Schering-Plough Products, LLC Terminated
Class I February 6, 2013 Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg, packaged in a)… Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets. Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals Terminated
Class II February 6, 2013 HILLYARD, Alcohol Free Foaming Instant Hand Sanitizer, Benzalkonium Chloride 0.10%, 1.25… Microbial Contamination of Non-Sterile Products: The product may be contaminated with bacteria. Hillyard GMP Terminated
Class II February 6, 2013 Carvedilol Tablets, USP, 12.5 mg, 500-count tablets per bottle, Rx only, Mylan… Failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness. Mylan Pharmaceuticals Inc. Terminated
Class II January 30, 2013 PredniSONE Tablets, USP, 20 mg, packaged in a) 100-count tablets per bottle (NDC… Presence of Foreign Substance: A complaint was received for black specks identified as stainless steel inclusions and… West-ward Pharmaceutical Corp. Terminated
Class II January 30, 2013 Lisinopril and Hydrochlorothiazide Tablets, 20 mg/25 mg, packaged in a) 100-count tablets… Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in… West-ward Pharmaceutical Corp. Terminated
Class II January 30, 2013 Propylthiouracil Tablets, USP, 50 mg, packaged in a) 100-count tablets per bottle (NDC… Presence of Foreign Substance: Uncharacteristic spots identified as steel corrosion, degraded tablet material and… West-ward Pharmaceutical Corp. Terminated
Class I January 30, 2013 Trastuzumab Kit containing 1 vial Trastuzumab (nominal content: 440 mg); 1 20 mL multiple… Presence of Particulate Matter: One lot of Bacteriostatic Water for Injection, USP diluent vials that were packed with… Genentech Inc Terminated
Class III January 30, 2013 Major Oral Peroxide (Carbamide Peroxide 10%), 2 fl oz (60 mL), Distributed by: Major… Stability data does not support expiration date: Stability data indicates the Carbamide Peroxide will degrade below… Axcentria Pharmaceuticals LLC Terminated
Class II January 30, 2013 Lisinopril Tablets, USP 40 mg, packaged in a) 100-count tablets per bottle (NDC… Presence of Foreign Substance: Uncharacteristic black spots identified as a food grade lubricant with trace amounts of… West-ward Pharmaceutical Corp. Terminated
Class III January 30, 2013 Flanax (aluminum hydroxide, magnesium hydroxide, and simethicone) Fast Acting Antacid,… Defective Container: Product lacks tamper evident breakaway band on cap. Belmora LLC Terminated
Class II January 23, 2013 I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, OR 97031 Lack of Assurance of Sterility: The product is being recalled because the product label does not state sterile in… James G. Cole, Inc. Terminated
Class II January 23, 2013 Prednisone tablets, USP, 10mg, Rx Only, Units of Use, NDC: a) 45802-303-67, 48-count… Presence of Foreign Substance(s); Perrigo has been notified of a recall by the manufacturer of this product, West-Ward… L. Perrigo Co. Terminated
Class III January 23, 2013 Divalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity, 100-count… Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the… Upsher Smith Laboratories, Inc. Terminated
Class III January 23, 2013 Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim,… Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite. Boehringer Ingelheim Roxane Inc Terminated
Class III January 23, 2013 Cabergoline CABERGOLINE Tablets, 0.5 mg, RX only, 8 count bottles, Manufactured For: TEVA… Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life Teva Pharmaceuticals USA, Inc. Terminated
Class II January 9, 2013 Omnipaque 240mg/mL PF, 300mg/mL PF, in 3 mL, 5 mL, and 10 mL, vials, manufactured by New… Lack of Assurance of Sterility New England Compounding Center Terminated
Class II January 9, 2013 Hyaluronidase 150 u/ml PF, 1 mL, 5 mL, and 10 mL vials, manufactured by New England… Lack of Assurance of Sterility New England Compounding Center Terminated
Class II January 9, 2013 Isovue 200 mg/mL PF and 300 mg/mL PF, Vials, manufactured by New England Compounding… Lack of Assurance of Sterility New England Compounding Center Terminated
Class I January 9, 2013 Methylprednisolone Acetate (PF) 80 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL… Non-Sterility New England Compounding Center Terminated
Class I January 9, 2013 Methylprednisolone Acetate 80 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL… Non-Sterility New England Compounding Center Terminated
Class II January 9, 2013 Betamethasone Repository 6 mg/mL PF Injection and Betamethasone Repository 6 mg/mL P… Lack of Assurance of Sterility New England Compounding Center Terminated
Class II January 9, 2013 Bupivacaine 0.25% PF, Bupivacaine 0.5% PF, and Bupivacaine 0.75% PF, manufactured by New… Lack of Assurance of Sterility New England Compounding Center Terminated
Class II January 9, 2013 Lidocaine/Dextrose 5%/7.5% PF, manufactured by New England Compounding Center,… Lack of Assurance of Sterility New England Compounding Center Terminated
Class I January 9, 2013 Methylprednisolone Acetate 40 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL… Non-Sterility New England Compounding Center Terminated
Class II January 9, 2013 Saline 10% and 3%, in 5 mL and 10 mL vials, manufactured by New England Compounding… Lack of Assurance of Sterility New England Compounding Center Terminated
Class II January 9, 2013 Epinephrine Injection USP, 1 mL, USP 1:1000 (1 mg/mL), SQ/IM, Hospira, Inc., Lake Forest,… Presence of Particulates; may contain glass particles Hospira Inc. Terminated
Class II January 9, 2013 Lidocaine 1% PF, 2% PF, and 4% PF, in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by… Lack of Assurance of Sterility New England Compounding Center Terminated
Class II January 9, 2013 Glycerin 100% PF, 1mL, 2 mL, and 5 mL vials, manufactured by New England Compounding… Lack of Assurance of Sterility New England Compounding Center Terminated
Class II January 9, 2013 Clonidine 100 mcg/mL PF, 1mL and 2 mL vials, manufactured by New England Compounding… Lack of Assurance of Sterility New England Compounding Center Terminated
Class I January 9, 2013 Methylprednisolone Acetate (PF) 40 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL… Non-Sterility New England Compounding Center Terminated
Class II January 9, 2013 Triamcinolone 10 mg/mL P, 40mg/mL P, 40mg/mL PF and 80 mg/mL PF in 1 mL, 2 mL, 5 mL, and… Lack of Assurance of Sterility New England Compounding Center Terminated
Class II January 9, 2013 Dexamethasone Sodium Phosphate 4 mg/mL vials PF, 6 mg/mL PF vials, and 8 mg/mL PF vials,… Lack of Assurance of Sterility New England Compounding Center Terminated
Class II January 9, 2013 Betamethasone Sodium Phosphate 6 mg/mL P Injection, Betamethasone Sodium Phosphate 6… Lack of Assurance of Sterility New England Compounding Center Terminated
Class II January 9, 2013 Synthroid Synthroid (Levothyroxine Sodium) tablets, 150 mcg (0.15 mg), 90 tablets per bottle, Rx… Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets. Abbott Laboratories Terminated
Class II January 2, 2013 Levothroid (levothyroxine sodium tablets, USP), 75 mcg., 100-count bottles, Rx only, NDC… Subpotent; 9-month stability interval Lloyd Inc. of Iowa Terminated
Class II January 2, 2013 Cymevene 500 mg Powder for Infusion, (ganciclovir), 50 mg/mL ganciclovir (reconstructed),… Lack of Assurance of Sterility; container closure issues with the bulk batch. F. Hoffmann-LaRoche Ltd. Terminated
Class II January 2, 2013 Thyro-Tab 0.075 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm… Subpotent; 9-month stability interval Lloyd Inc. of Iowa Terminated
Class II January 2, 2013 Levothroid (levothyroxine sodium tablets, USP), 50 mcg., 100-count bottles, Rx only, NDC… Subpotent; 9-month stability interval Lloyd Inc. of Iowa Terminated
Class II January 2, 2013 Levothyroxine Sodium Tablets, USP, 175 mcg in 90 ct bottles, Manufactured by Patheon… Subpotent; 15 month stability Alara Pharmaceutical Co Terminated
Class II January 2, 2013 Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm… Subpotent; 9-month stability interval Lloyd Inc. of Iowa Terminated
Class II December 26, 2012 NALBUPHINE HYDROCHLORIDE Nalbuphine HCl Injection, 20 mg/mL, 10 mL Multiple-dose Fliptop Vial, Rx only, Hospira,… Lack of Assurance of Sterility: Complains of a loose crimp applied to the fliptop vial; and a missing stopper and flip… Hospira, Inc. Terminated
Class III December 26, 2012 Clean & Clear advantage, 3-in-1 foaming wash 8 FL. OZ. (240 mL) bottle, OTC, Distributed… Superpotent (Single Ingredient Drug): salicylic acid Johnson & Johnson Terminated
Class III December 26, 2012 CellCept (mycophenolate mofetil) capsules, 250 mg, packaged in a) 12 x 120-count bottles… Short Fill: some bottles contained less than 120-count per labeled claim. Genentech, Inc. Terminated
Class III December 26, 2012 Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1… Impurities/Degradation Products: Out-of-specification results were obtained for a known impurities. Watson Laboratories Inc Terminated
Class II December 26, 2012 Procrit (epoetin alfa) injection, 20000 units/mL, 4 mL vial; Mfg By: Amgen Inc., Thousand… Presence of Particulate Matter: glass delamination Physicians Total Care, Inc. Terminated
Class III December 26, 2012 Choletec - Kit for the Preparation of Technetium Tc 99m Mebrofenin, 10 vials per box,… Presence of Particulate Matter; potential for charcoal particulates Bracco Diagnostic Inc Terminated
Class II December 26, 2012 Lidocaine Hydrochloride Lidocaine HCl Injection, USP, 1% (10 mg/mL), 30 mL Single-dose Teartop Vial, packaged in… Presence of Particulate Matter: Report of a vial containing visible particulate matter embedded in the glass wall which… Hospira, Inc. Terminated
Class III December 19, 2012 Enjuvia (synthetic conjugated estrogens, B) tablets, 0.625 mg, 30-count tablets per… Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay… Physicians Total Care, Inc. Terminated
Class III December 19, 2012 Enjuvia (synthetic conjugated estrogens, B) tablets, 0.9mg, 30-count tablets per bottle,… Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay… Physicians Total Care, Inc. Terminated
Class III December 19, 2012 Enjuvia (synthetic conjugated estrogens, B) tablets, 0.3mg, 30-count tablets per bottle,… Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay… Physicians Total Care, Inc. Terminated
Class II December 12, 2012 Nutropin AQ NuSpin 20 (somatropin (rDNA origin) injection} 20 mg/ 2mL Genentech, South… Miscalibrated and/or Defective Delivery System: Genentech has received complaints for Nutropin AQ NuSpin 10 & 20… Genentech Inc Terminated
Class II December 12, 2012 Levothroid (levothyroxine sodium tablets, USP), 112 mcg., 100-count bottles, Rx only, NDC… cGMP Deviations; does not meet in process specification requirements Lloyd Inc. of Iowa Terminated
Class II December 12, 2012 Levothroid (levothyroxine sodium tablets, USP), 137 mcg., 100-count bottles, Rx only, NDC… cGMP Deviations; does not meet in process specification requirements Lloyd Inc. of Iowa Terminated
Class II December 12, 2012 Thyro-Tab 0.137 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm… cGMP Deviations; does not meet in process specification requirements Lloyd Inc. of Iowa Terminated
Class II December 12, 2012 Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm… cGMP Deviations; does not meet in process specification requirements Lloyd Inc. of Iowa Terminated
Class II December 12, 2012 Thyro-Tab 0.088 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm… cGMP Deviations; does not meet in process specification requirements Lloyd Inc. of Iowa Terminated
Class II December 12, 2012 Nutropin AQ NuSpin 10 (somatropin (rDNA origin) injection} 10 mg/ 2mL Genentech, South… Miscalibrated and/or Defective Delivery System: Genentech has received complaints for Nutropin AQ NuSpin 10 & 20… Genentech Inc Terminated
Class II December 12, 2012 Levothroid (levothyroxine sodium tablets, USP),125 mcg., 100-count bottles, Rx only, NDC… cGMP Deviations; does not meet in process specification requirements Lloyd Inc. of Iowa Terminated
Class II December 12, 2012 Levothroid (levothyroxine sodium tablets, USP), 300 mcg., 100-count bottles, Rx only, NDC… cGMP Deviations; does not meet in process specification requirements Lloyd Inc. of Iowa Terminated
Class II December 12, 2012 Levothroid (levothyroxine sodium tablets, USP), 50 mcg., 100-count bottles, Rx only, NDC… cGMP Deviations; does not meet in process specification requirements Lloyd Inc. of Iowa Terminated
Class II December 12, 2012 Thyro-Tab 0.125 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm… cGMP Deviations; does not meet in process specification requirements Lloyd Inc. of Iowa Terminated
Class II December 12, 2012 Thyro-Tab 0.300 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm… cGMP Deviations; does not meet in process specification requirements Lloyd Inc. of Iowa Terminated
Class II December 12, 2012 Thyro-Tab 0.112 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm… cGMP Deviations; does not meet in process specification requirements Lloyd Inc. of Iowa Terminated
Class II December 12, 2012 Levothroid (levothyroxine sodium tablets, USP), 88 mcg., 100-count bottles, Rx only, NDC… cGMP Deviations; does not meet in process specification requirements Lloyd Inc. of Iowa Terminated
Class III December 12, 2012 Novarel¿ (Chorionic Gonadotropin for injection, USP), 10,000 USP FOR INTRAMUSCULAR USE… Labeling; incorrect or missing insert; Warnings portion of the Package Insert is missing the warning statement:… Ferring Pharmaceuticals Inc Terminated
Class II December 12, 2012 traMADOL Hydrochloride Tablets, USP 50 mg, 1000-count tablets per bottle, Manufactured… Adulterated Presence of Foreign Tablets: A customer complaint was received that a bottle of Tramadol HCl Tablets USP 50… Caraco Pharmaceutical Laboratories, Ltd. Terminated
Class II December 12, 2012 Fluorouracil Fluorouracil Topical Cream USP, 5%, 40 g Tube, Rx only, Mfd. by: Taro Pharmaceutical… Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples. Taro Pharmaceuticals U.S.A., Inc. Terminated
Class II December 5, 2012 Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by… Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the… Boehringer Ingelheim Roxane Inc Terminated
Class I December 5, 2012 Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information in Spanish) Marketed without an approved NDA/ANDA: Samantha Lynn Inc. is recalling Reumofan Plus Tablets because it contains… Samantha Lynn, Inc Terminated
Class II December 5, 2012 Arranon (nelarabine) Injection 5mg/mL, 50mL Vials, Rx only, For I.V. Infusion only,… Impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits. GlaxoSmithKline, LLC. Terminated
Class II December 5, 2012 Vicks NyQuil Cold & Flu, Nighttime Relief, 12 FL OZ bottle, Dist. by Proctor and Gamble,… Labeling Illegible: Portions of the product labeling in the area of the dosing directions, the warnings & other… Procter & Gamble Co Terminated
Class II December 5, 2012 ATORVASTATIN CALCIUM Atorvastatin Calcium Tablets, 20 mg, 90 tablets per bottle, Rx only, Manufactured for:… Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass… Ranbaxy Inc. Terminated
Class II December 5, 2012 Tacrolimus Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc.,… Failed USP Content Uniformity Requirements: OOS result reported on retained samples. Mylan LLC. Terminated
Class III December 5, 2012 ADVAIR HFA Advair HFA (fluticasone propionate/salmeterol) Inhalation Aerosol, 45mcg/21 mcg 60… Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution… GlaxoSmithKline, LLC. Terminated
Class II December 5, 2012 ATORVASTATIN CALCIUM Atorvastatin Calcium Tablets, 10 mg, 90 tablets per bottle, Rx only, Manufactured for:… Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass… Ranbaxy Inc. Terminated
Class II December 5, 2012 ATORVASTATIN CALCIUM Atorvastatin Calcium Tablets, 40 mg, a) 90 tablets per bottle, b) 500 tablets per bottle,… Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass… Ranbaxy Inc. Terminated
Class III December 5, 2012 ADVAIR HFA Advair HFA (fluticasone propionate 45 mcg and salmeterol 21 mcg) Inhalation Aerosol, 12g,… Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution… GlaxoSmithKline, LLC. Terminated
Class I November 28, 2012 HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx… Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent… Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals Ongoing
Class II November 28, 2012 Limed Bone Gelatin, packaged in six 125 kg fiber drums and labeled in part PO NO.: P8095… Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by… American Enterprises LLC dba Sterling Gelatin Terminated
Class II November 28, 2012 Orajel Kids My Way! Anticavity Fluoride (sodium fluoride) toothpaste, 0.24%, 3 oz (85 g)… CGMP Deviations: Product was made with an incorrect ingredient, Laureth-9 was mistakenly substituted for PEG. Church & Dwight Inc Terminated
Class I November 28, 2012 Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per… Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets. Watson Laboratories Inc Terminated
Class II November 28, 2012 Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd By: Dr. Reddy's… Failed USP Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS… Dr. Reddy's Laboratories, Inc. Terminated
Class II November 28, 2012 ATORVASTATIN CALCIUM Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manufactured… Adulterated Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an… Ranbaxy Inc. Terminated
Class II November 21, 2012 All Sterile Products manufactured by NECC (New England Compounding Center), Framingham,… Lack of Assurance of Sterility New England Compounding Center Terminated
Class III November 21, 2012 Tobramycin Ophthalmic Oint., 0.3%, 5ml bottle, (Generic for: Tobrex), Rx only, Sterile,… Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of… Stat Rx USA Terminated
Class II November 21, 2012 All Non-Sterile Products manufactured by Ameridose LLC, Westborough, MA. A complete list… GMP deficiencies Ameridose LLC Terminated
Class III November 21, 2012 Venlafaxine ER 150mg, 30 Tabs bottle, Generic for: Effexor, Packaged and Distributed by:… Labeling: Label Mix-up: Product was incorrectly labeled,"Tabs" instead of "Capsules." Stat Rx USA Terminated
Class II November 21, 2012 All Non Sterile Products manufactured by NECC (New England Compounding Center),… GMP Deviations New England Compounding Center Terminated
Class III November 21, 2012 Lemon Hand Sanitizing Wipes [n-alkyl dimethyl benzyl ammonium chloride (0.1%) and n-alkyl… CGMP Deviations: The products were manufactured with raw material which contain unknown particles believed to be water… ITW Dymon Terminated
Class II November 21, 2012 All Sterile Products manufactured by Ameridose LLC, Westborough, MA. A complete list of… Lack of assurance of sterility Ameridose LLC Terminated
Class III November 14, 2012 AcneFree Original Strength Terminator (benzoyl peroxide 5% w/v), 1 oz. (28 g) tube, Dist.… Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient.… Valeant Pharmaceuticals Terminated
Class III November 14, 2012 AcneFree 3-in-1 Acne Night Repair Foam (retinol + salicylic acid 1.5% w/v), 3 oz (85 g)… Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicylic acid ingredient.… Valeant Pharmaceuticals Terminated
Class III November 14, 2012 AcneFree Oil-Free Acne Cleanser (benzoyl peroxide 2.5% w/v), 8 fl. oz. (237 mL) bottle,… Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient.… Valeant Pharmaceuticals Terminated
Class III November 14, 2012 AcneFree 24 Hour Severe Acne Clearing System containing 1-count 4 fl oz (118 mL) bottle… Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient.… Valeant Pharmaceuticals Terminated
Class III November 14, 2012 AcneFree Acne Pore Cleanser (benzoyl peroxide 2.5% w/v), 3 oz (85 g) canister, Dist. by:… Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient.… Valeant Pharmaceuticals Terminated
Class II November 14, 2012 Northstar Zolpidem Tartrate Tablets USP 10 mg. Manufactured for Northstar RX, LLC… Adulterated Presence of Foreign Tablets: This product is being recalled becaiuse 30 valacyclovir hydrochloride tablets… Aurobindo Pharma LTD Terminated
Class I November 14, 2012 Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL… Lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be contaminated with… Merit Medical Systems, Inc Terminated
Class III November 14, 2012 AcneFree 24 Hour Clearing System containing 1-count 4 fl oz (118 mL) Oil-Free Purifying… Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient.… Valeant Pharmaceuticals Terminated
Class III November 14, 2012 AcneFree Acne Astringent Toner Pads (salicylic acid 2% w/v); 60-count pads per jar, Dist.… Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicyclic acid active ingredient. Valeant Pharmaceuticals Terminated
Class III November 14, 2012 AcneFree Severe Maximum Strength Acne Pore Cleanser (benzoyl peroxide 5% w/v), 3 oz (85… Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient.… Valeant Pharmaceuticals Terminated
Class II November 7, 2012 UP & UP brand, kid's foaming hand sanitizer, alcohol free, 99.9% effective against germs,… Microbial Contamination of Non-Sterile Products: Laboratory findings of high total plate count above specification. DermaCare, Inc. Terminated
Class I November 7, 2012 Z-ROCK All Natural Male Supplement. 1 capsule blister pack, UPC 0 00309 50792 7,… Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil. Coral Rock Man, Inc. Terminated
Class I November 7, 2012 X-ROCK For Men, Dietary Supplement, Manufactured by CRM Laboratories, Distributed by… Marketed Without an Approved NDA/ANDA: product tested positive for PDE-5 Sildenafil and PDE-5… XRock Industries, LLC Terminated
Class II November 7, 2012 UP & UP brand, kid's foaming hand sanitizer, alcohol free, 99.9% effective against germs,… Microbial Contamination of Non-Sterile Products: Laboratory findings of high total plate count above specification. DermaCare, Inc. Terminated
Class I November 7, 2012 X-ROCK 3 Day Pill For Men, supplied in 1 and 2 capsule blister packs and 6, 12 and 24… Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil. Coral Rock Man, Inc. Terminated
Class II November 7, 2012 Leucovorin Calcium Injection USP, single use vials, 10mg/mL; 50mL, Rx only, Manufactured… Presence of Particulate Matter: visible crystalline particulates and the discovery of crystalline particulate in a… Ben Venue Laboratories Inc Terminated
Class II October 31, 2012 Equate Fiber Therapy, 100% Natural Psyllium Husk Fiber, Fiber Laxative/Fiber Supplement,… Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by… Raritan Pharmaceuticals, Inc. Terminated
Class II October 31, 2012 Berkley & Jensen Fiber Capsules, Fiber Laxative/Fiber Supplement, 100% Natural Psyllium… Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by… Raritan Pharmaceuticals, Inc. Terminated
Class II October 31, 2012 Best Choice Health Care, Psyllium Fiber Supplement, 100% natural Psyllium Fiber Laxative,… Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by… Raritan Pharmaceuticals, Inc. Terminated
Class II October 31, 2012 Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physician… Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly labeled as Kombiglyze… Bristol-myers Squibb Company Terminated
Class II October 31, 2012 Leader Fiber Capsules, 100% Natural Psyllium Fiber Laxative, Dietary Fiber Supplement,… Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by… Raritan Pharmaceuticals, Inc. Terminated
Class II October 31, 2012 Wal-Mucil 100% Natural Fiber, 100% Natural Psyllium Seed Husk, Fiber Laxative/Supplement,… Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by… Raritan Pharmaceuticals, Inc. Terminated
Class II October 31, 2012 Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physician… Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly labeled as Kombiglyze… Bristol-myers Squibb Company Terminated
Class II October 31, 2012 Premier Value Fiber Capsules, Fiber Capsules, 100% Natural Psyllium Fiber, Relieves… Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by… Raritan Pharmaceuticals, Inc. Terminated
Class III October 31, 2012 Earth Force, Ltd., Power Towels, QS Plus Hand Sanitizing Wipes (antiseptic), 50… Chemical Contamination: QS Plus wipes were found to be contaminated with different substance (7820, Graffiti Remover). Abc Compounding Company Inc Terminated
Class II October 31, 2012 Necon 1/35-28 (norethindrone and ethinyl estradiol) Tablets USP, 1 mg/35 mcg, inert… Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots… Watson Laboratories Inc Terminated
Class I October 31, 2012 BiCNU (Carmustine for injection) 100 mg and Diluent Rx Only BiCNU manufactured by: Ben… Superpotent (Single Ingredient) Drug: All BiCNU lots within expiration which contain carmustine vial lots manufactured… Bristol-myers Squibb Company Terminated
Class II October 31, 2012 Up&Up Psyllium Fiber Supplement, 100% natural psyllium husk, Fiber Therapy for… Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by… Raritan Pharmaceuticals, Inc. Terminated
Class II October 31, 2012 Wal-Mucil Plus Calcium Fiber Capsules,100% Natural Fiber, 100% Natural Psyllium Seed… Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by… Raritan Pharmaceuticals, Inc. Terminated
Class II October 31, 2012 Lutera (levonorgestrel and ethinyl estradiol) Tablets USP, 0.1 mg/0.02 mg, inert tablets,… Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots… Watson Laboratories Inc Terminated
Class II October 31, 2012 CVS Pharmacy Fiber Capsules for Regularity, Dietary Fiber Supplement, 100 Capsules per… Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by… Raritan Pharmaceuticals, Inc. Terminated
Class II October 31, 2012 Premier Value Fiber Plus Calcium Supplement Capsules, 120 capsules per bottle,… Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by… Raritan Pharmaceuticals, Inc. Terminated
Class II October 31, 2012 Doxazosin Tablets, USP, 2 mg, 100 count bottles, labeled in part ***Manufactured in… Cross Contamination w/Other Products: During stability testing chromatographic review revealed extraneous peaks… Mylan Pharmaceuticals Inc. Terminated
Class II October 31, 2012 Simply Right Healthcare Fiber Capsules, 100% Natural Psyllium Fiber, Fiber Supplement,… Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by… Raritan Pharmaceuticals, Inc. Terminated
Class II October 31, 2012 Zenchent (norethindrone and ethinyl estradiol) Tablets USP, 0.4 mg/0.035 mg, 28-count… Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots… Watson Laboratories Inc Terminated
Class II October 31, 2012 Zovia (ethynodiol diacetate and ethinyl estradiol) Tablets USP, 1 mg/35 mcg, inert… Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots… Watson Laboratories Inc Terminated
Class II October 31, 2012 Perphenazine Tablets, USP, 8 mg, 100-count tablets per bottle, Manufactured for:… Tablet Separation: Possibility of cracked or split coating on the tablets. Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals Terminated
Class II October 31, 2012 DRxChoice Fiber Capsules, 25 capsules per bottle, Psyllium Husk Fiber, Mfg. by Raritan… Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by… Raritan Pharmaceuticals, Inc. Terminated
Class II October 31, 2012 Necon 10/11 (norethindrone and ethinyl estradiol) Tablets USP, 0.5 mg/35 mcg, 1 mg/35… Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots… Watson Laboratories Inc Terminated
Class I October 31, 2012 HYDROMORPHONE HYDROCHLORIDE HYDROmorphone HCl Injection, USP, 2 mg/mL, 1 mL fill in a 2.5 mL Carpuject prefilled… Superpotent (Single Ingredient) Drug: The prefilled cartridge unit has been found to be overfilled and contain more… Hospira Inc. Terminated
Class II October 24, 2012 Colloidal Silver, 100 ppm TDS, Natural Mineral Supplement, sold in a) 2 fl.oz (59.15 mL),… Marketed Without An Approved NDA/ANDA: This product is being recalled because FDA issued a final rule establishing that… Earthborn Products, Inc. Terminated
Class III October 24, 2012 Cetirizine Hydrochloride Children's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manufactured in… Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2) Sandoz Incorporated Terminated
Class III October 17, 2012 Prometh VC with Codeine Cough Syrup, CV, Each 5mL contains: Codeine phosphate 10mg;… Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown… Actavis Mid Atlantic LLC Terminated
Class II October 17, 2012 Moexipril HCl Tablets 7.5mg, 100 tabs, Rx Only, Paddock Laboratories, Inc., Minneapolis,… Paddock Laboratories, LLC are recalling one lot (2012028142) of Moexipril HCl Tablets 7.5mg (expiration 1/2014) because… Paddock Laboratories, LLC Terminated
Class III October 17, 2012 Prometh VC Plain, Each 5mL contains: Promethazine Hydrochloride 6.25mg & Phenylephrine… Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown… Actavis Mid Atlantic LLC Terminated
Class III October 10, 2012 buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, UD 100 Tablets (10 x 10)… Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability… McKesson Packaging Services Terminated
Class III October 10, 2012 Famotidine Tablets USP, 20 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals, Inc.,… Impurities/Degradation Products: Out of specification results for Related Compound during routine stability testing. Mylan Pharmaceuticals Inc. Terminated
Class III October 10, 2012 buPROPion Hydrochloride Extended-Release Tablets (XL), 150 mg, UD 100 Tablets (10 x 10)… Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability… McKesson Packaging Services Terminated
Class II October 10, 2012 Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose… Crystallization: Presence of crystals of Nimodipine within the capsule solution. Caraco Pharmaceutical Laboratories Ltd. Terminated
Class II October 10, 2012 ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol)… Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility… Carefusion 213, Llc Terminated
Class II October 3, 2012 5% Dextrose and 0.45% Sodium Chloride Injection USP, packaged in a 500 mL AVIVA… Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene… Baxter Healthcare Corp. Terminated
Class I October 3, 2012 Japan Weight Loss Blue Capsules, 9 g (300 mg), 30 count box, Green algae lipotropic (fat… Marketed Without an Approved ANDA/NDA: presence of sibutramine www.vitaminbestbuy.com Terminated
Class II October 3, 2012 10% Dextrose Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter… Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene… Baxter Healthcare Corp. Terminated
Class I October 3, 2012 Man King Capsules, 2800 mg, boxes of 5 packets, OTC, Developed by: American Wanbao… Marketed Without an Approved ANDA/NDA: presence of sildenafil. www.vitaminbestbuy.com Terminated
Class II October 3, 2012 Atrovent HFA Inhalation Aerosol, (ipratropium bromide) 12.9 grams, 200 metered… Label Mix up; side panel of sticker label applied by Dispensing Solutions Inc. incorrectly indicates product name as… Dispensing Solutions, Inc Terminated
Class III October 3, 2012 Thallous Chloride Tl 201 Injection, Diagnostic Sterile, Non-Pyrogenic Solution, a) 2.8 mL… Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct… Mallinckrodt Inc Terminated
Class II October 3, 2012 0.9% Sodium Chloride Injection USP, packaged in a) 250 mL AVIVA Container, product code… Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene… Baxter Healthcare Corp. Terminated
Class II October 3, 2012 Lactated Ringer's Injection USP, packaged in a) 250 mL AVIVA Container, product code… Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene… Baxter Healthcare Corp. Terminated
Class I October 3, 2012 Hard Ten Days Capsule, 4500 mg, boxes of 6 packets, OTC, Developed by: American Federal… Marketed Without an Approved ANDA/NDA: presence of sildenafil www.vitaminbestbuy.com Terminated
Class II October 3, 2012 Fentanyl Transdermal System, 100 mcg/h, each transdermal system contains: 10 mg fentanyl… Subpotent; some patches may not contain fentanyl gel Actavis Terminated
Class II October 3, 2012 5% Dextrose Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E0062,… Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene… Baxter Healthcare Corp. Terminated
Class I October 3, 2012 Vecuronium Bromide for Injection, For IV use only, 20 mg per vial, 10 x 10 mg Vials,… Presence of Particulate Matter Ben Venue Laboratories Inc Terminated
Class II October 3, 2012 Levetiracetam Levetiracetam Tablets, USP 500 mg, 500 count bottle, Rx only, Manufactured for: Mylan… Adulterated Presence of Foreign Tablets: Pharmaceutical manufacturer may have distributed foreign tablets in bottles of… Mylan Pharmaceuticals Inc. Terminated
Class II October 3, 2012 CARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx Only, For Elution of sterile… GMP deviation; Sr-82 levels exceeded alert limit specification Bracco Diagnostics Inc Terminated
Class II October 3, 2012 Synthroid Synthroid (levothyroxine sodium) Tablets USP, 75 mcg, Rx Only, 90-Count Bottle, Abbott… Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may… Abbott Laboratories Terminated
Class II October 3, 2012 Synthroid Synthroid (levothyroxine sodium) Tablets USP, 112 mcg, Rx Only, 90-Count Bottle, Abbott… Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may… Abbott Laboratories Terminated
Class II October 3, 2012 Synthroid Synthroid (levothyroxine sodium) Tablets USP, 50 mcg, Rx Only, 90-Count Bottle, Abbott… Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may… Abbott Laboratories Terminated
Class II October 3, 2012 Naproxen Sodium NAPROXEN TABLETS USP, 500 mg, 100-count Tablets per bottle, Rx only, Manufactured by:… Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90-count Pravastatin… Glenmark Generics Inc., USA Terminated
Class II October 3, 2012 propofol Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200… Presence of Particulate Matter: A single visible particulate was observed and confirmed in sample bottles of the… Hospira Inc. Terminated
Class II September 26, 2012 Dukal Corporation BZK Swab, First Aid Antiseptic, (Benzalkonium Chloride), 0.133% w/v,… Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufacturer) Dukal Corp. Terminated
Class II September 26, 2012 ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative Skin… Lack of Assurance of Sterility: A customer complaint reported some units had incomplete seals (open seals) on the… Carefusion 213, Llc Terminated
Class II September 26, 2012 ZEE Antiseptic Wipes, First Aid Antiseptic, Benzalkonium chloride 0.133% (effective… Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufacturer) Dukal Corp. Terminated
Class III September 26, 2012 Pramipexole Dihydrochloride Tablets, 0.25 mg, 90-count tablets per bottle, Rx only,… Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12… Sandoz Incorporated Terminated
Class III September 26, 2012 Enalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, Ft. Run, KY… Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength. Apace KY LLC Terminated
Class III September 26, 2012 Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, Rx only,… Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12… Sandoz Incorporated Terminated
Class II September 26, 2012 Carboplatin Carboplatin Injection, 10 mg/mL, 45 mL Multi-Dose Vial, Rx only, antineoplastic/cytotoxic… The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection… Hospira Inc. Terminated
Class II September 26, 2012 Methotrexate Methotrexate Injection, USP, 25 mg/mL, 40 mL Single Dose Vial, Rx only,… The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection… Hospira Inc. Terminated
Class II September 26, 2012 Paclitaxel Paclitaxel Injection, 6 mg/mL, 50 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic… The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection… Hospira Inc. Terminated
Class II September 26, 2012 Cytarabine Cytarabine Injection, 20 mg/mL, 50 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic… The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection… Hospira Inc. Terminated
Class II September 12, 2012 Little Remedies For Tummys, Stimulant Laxative (sennosides) Drops, 1 FL OZ (30 mL), Dist.… Subpotent (Single Ingredient) Drug: This product is being recalled because of sub-potency of the sennosides. Medtech Products, Inc. Terminated
Class III September 5, 2012 MultiHance Bracco Diagnostics multihance (gadobenate dimeglumine) injection, 529 mg/mL, 20ml, Rx… Short Fill: The product is being recalled due to a potential underfill of the affected vials. Bracco Diagnostics Inc Terminated
Class III September 5, 2012 Oasis Age Essential (cetylpyridinium chloride) Mouthwash, 0.06%, 473 mL (16 fl oz)… Microbial Contamination of a Non-Sterile Products: Three product lots are contaminated with Burkholderia cepacia. Natural Essentials Inc Terminated
Class II September 5, 2012 Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters per carton, Rx… Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. recall for… American Health Packaging Terminated
Class III September 5, 2012 METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, This cup delivers 10 mL, Rx Only,… Labeling: Correct Labeled Product Miscart/Mispack: The shipper label displayed "5 mL x 50," instead of "10 mL x 50," VistaPharm, Inc. Terminated
Class II September 5, 2012 CosMedix Serious Protection, Natural SPF 28 Sunscreen, 3.3 fl.oz/100mL (100 g),… Microbial Contamination of Non Sterile Product; mold Island Kinetics dba Covalence Terminated
Class II September 5, 2012 Eco-Dent Sparkling Clean Mint Ultimate Essential MouthCare, Natural Daily Rinse and Oral… Microbial Contamination of Non-Sterile Products; Product was found to be contaminated with Sphingomonas paucimobilis… Capco Custom Packaging Inc Terminated
Class III September 5, 2012 Capex Shampoo (fluocinolone acetonide), Topical Shampoo, 0.01%, Rx only, For Topical Use… Subpotent; fluocinolone acetonide. Galderma Laboratories, L.P. Terminated
Class II September 5, 2012 Leflunomide Leflunomide tablets, 10 mg, a) 30-count bottle (NDC 60505-2502-1), b) 1000-count bottle… Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications. Apotex Corp. Terminated
Class II September 5, 2012 Leflunomide Leflunomide tablets, 20 mg, 1000-count bottle, Rx only, Manufactured for Apotex Corp.,… Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications. Apotex Corp. Terminated
Class II September 5, 2012 MultiHance Multihance Multipack (gadobenate dimeglumine) injection, 529 mg/mL, Pharmacy Bulk Package… Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage. Bracco Diagnostics Inc Terminated
Class II September 5, 2012 VENTOLIN Ventolin HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 Metered… Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification. GlaxoSmithKline Inc Terminated
Class III September 5, 2012 AZELASTINE HYDROCHLORIDE Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays),… CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product. Apotex Corp. Terminated
Class II September 5, 2012 propofol Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 ml Single patient infusion… Presence of Particulate Matter: A single visible particulate was observed and confirmed in a sample bottle during… Hospira Inc. Terminated
Class I August 29, 2012 V Maxx Rx, All Natural Male Enhancement, a) 1-count blister pack UPC Code 2802803561; b)… Marketed Without An Approved NDA/ANDA: Samples tested by FDA were found to contain sulfoaildenafil, an analogue of… The Menz Club, LLC Terminated
Class II August 29, 2012 CMS-2374-R4 Custom US Breast Core Biopsy Tray, Sterile, contains Sodium Chloride 0.9% 50… Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject… Custom Medical Specialties, Inc. Terminated
Class II August 29, 2012 Xactdose Phenytoin Oral Suspension, USP, 125mg/ 5 mL, supplied in 5 mL unit dose cups,… Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay… VistaPharm, Inc. Terminated
Class II August 29, 2012 Mercaptopurine Tablets, USP, 50 mg, packaged in a) 60-count tablets per bottle (NDC… Failed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dissolution. Prometheus Laboratories Inc. Terminated
Class III August 29, 2012 Morton, Sodium Chloride, USP, Granular, packaged in kraft paper bags, fiber drums, and… Impurities/Degradation Products: The product was found to contain a slightly out of specification level of bromides,… Morton Salt Co. Terminated
Class II August 29, 2012 CMS-8934 Custom Phlebectomy Tray, Sterile, contains Sodium chloride 0.9% 50 mL,… Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject… Custom Medical Specialties, Inc. Terminated
Class II August 29, 2012 Custom Access Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Re-order #:… Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject… Custom Medical Specialties, Inc. Terminated
Class II August 29, 2012 Hipoglos Ointment (zinc oxide and lanolin), Helps prevent and treat diaper rash, skin… Misbranded Victus, Inc. Terminated
Class II August 29, 2012 Daytrana Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 hours (1.6… Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the… Noven Pharmaceuticals, Inc. Terminated
Class II August 29, 2012 Daytrana Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3… Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the… Noven Pharmaceuticals, Inc. Terminated
Class II August 29, 2012 Daytrana Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2… Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the… Noven Pharmaceuticals, Inc. Terminated
Class II August 22, 2012 FOLIC ACID 10MG/ML INJECTABLE 60 ML (1 PRODUCT) Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 HUMULIN-R INSULIN, 10ML VIAL** 100U/ML INJECTABLE 10 MLS (1 PRODUCT) Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 LIDOCAINE/EPINEPHRINE/BUPIVACAINE, PF 1%/0.00025%/0.375% OPHTHALMIC 30 ML 48 ML 60 ML 90… Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 DEPO-TESTOSTERONE, MDV, 10ML** 200MG/ML INJECTABLE 10 ML (1 PRODUCT) Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 OXYTOCIN 10UNITS/ML INJECTABLE 25 ML; OXYTOCIN**(25X1ML) 10U/ML INJECTABLE 25 MLS (2… Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 DMPS 250MG/10ML INJECTABLE 20 ML, 30 ML; DMPS 50MG/ML (500MG/10ML) INJECTABLE 10 ML, 5 ML… Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 PACLITAXEL 6MG/ML INJECTABLE 500 ML (1 PRODUCT) Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 ETHYL ALCOHOL 10% INJECTABLE 30 ML; ETHYL ALCOHOL 100%INJECTABLE 10 ML, 100 ML, 20 ML, 40… Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 DIAZEPAM (IM/IV) 1MG/ML INJECTABLE 40 ML, 60 ML; DIAZEPAM (IM/IV) 5MG/ML INJECTABLE 2 ML,… Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 GLYCERIN 99.5% OPHTHALMIC 10 ML, 5 ML, 7.5 ML; GLYCERIN 100% OPHTHALMIC 15 ML (4… Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 NANDROLONE DECANOATE (H) 200MG/ML INJECTABLE 1 ML 5 ML 6 ML; NANDROLONE DECANOATE… Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% NACL) 50MG/1000MCG/7.5MG/ML INTRATHECAL 18 ML;… Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 TROPICAMIDE OPHTHALMIC P.F. 1% SOLUTION 30 ML (1 PRODUCT) Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 L-TRYPTOPHAN 15MG/ML INJECTABLE 60 ML (1 PRODUCT) Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 BUPIVACAINE/MORPHINE SULFATE, P.F. 2.5MG/10MG/ML INTRATHECAL 40 ML; BUPIVACAINE/MORPHINE… Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 VANCOMYCIN/DEXAMETHASONE, LYOPHILIZED 1%/0.1% KIT 2 KIT 20 KIT 24 KIT (3 DIFFERENT… Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 BRILLIANT BLUE G, P.F. 0.025% OPHTHALMIC 10 ML, 20 ML, 26 ML, 4 ML; BRILLIANT BLUE G,… Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 SODIUM BICARBONATE 4% INJECTABLE 10 ML 5 ML; SODIUM BICARBONATE 8.4% INJECTABLE 150 ML 50… Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 HYDROXOCOBALAMIN**(VIT B-12) 1000MCG/ML INJECTABLE 30 ML Injectable (4 DIFFERENT PRODUCTS) Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class III August 22, 2012 Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01% Topical Oil (Scalp Oil), 4 fl oz… Subpotent; fluocinolone acetonide Hill Dermaceuticals, Inc. Terminated
Class II August 22, 2012 ALTEPLASE, SDPF - (0.05ML SYRINGE, 30G, 1/2") 1000MCG/ML INJECTABLE 0.05 ML; ALTEPLASE,… Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 EDTA DISODIUM SOLUTION 33.6MG/ML (0.1 MOLAR) OPHTHALMIC 15 ML; EDTA CALCIUM DISODIUM… Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 TROPICAMIDE/PHENYLEPHRINE OPHTHALMIC 15:1 SOLUTION 128 ML 480 ML 496 ML 576 ML 90 ML (5… Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE 10 ML 24 ML 500 ML; KETOROLAC TROMETHAMINE… Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 CEFAZOLIN IN ARTIFICIAL TEARS 50MG/ML OPHTHALMIC 10 ML; CEFAZOLIN VIAL*(25X1GM) 1GM… Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 KENALOG-40** (MDV 10ML VIAL) 40MG/ML INJECTABLE 50 ML (1 PRODUCT) Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 SESAME OPHTHALMIC OIL 60 ML (1 PRODUCT) Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 HYALURONIC ACID SODIUM SALT 10MG/ML INJECTABLE 100 ML, 20 ML; HYALURONIC ACID SODIUM… Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 ACETIC ACID, IRRIGATION 3% SOLUTION 500 ML (1 PRODUCT) Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 DICLOFENAC SODIUM, SDPF - (0.1ML SYRINGE, 30G, 1/2") 500MCG/0.1ML INJECTABLE 0.5 ML, 2… Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 CISPLATIN 1MG/ML INJECTABLE 1000 ML, 2000 ML (2 DIFFERENT PRODUCTS) Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 TAURINE 50MG/ML INJECTABLE 120 ML 30 ML 40 ML 60 ML (4 DIFFERENT PRODUCTS) Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 CYCLOPENT/FLURBIPR/PHENYLEPH/PROPARACAINE .25%/0.0075%/0.625%/0.125% OPHTHALMIC 56 ML, 70… Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 VORICONAZOLE OPHTHALMIC 1% (10MG/ML) SOLUTION 15 ML; VORICONAZOLE OPHTHALMIC, (0.5ML, LL… Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 METHIONINE/INOSITOL/CHOLINE CHLORIDE/CHROM/B12 (C) 0.8/1.6/1.6/0.0001/0.03% INJE 10 ML… Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 ULTRA-TEST 200 (CYP 80%/PROP 20%) 200MG/ML INJECTABLE 1 ML 10 ML 10 MLS 12 ML 15 ML 18 ML… Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 G-C-P 0.1%/0.1%/0.05% SOLUTION 250 ML, 250 MLS, 500 ML (3 DIFFERENT PRODUCTS) Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 PAPAVERINE/PHENTOLAMINE/ATROPINE NS 3.6MG/0.4MG/0.04MG INJECTABLE 13 ML (1 PRODUCT) Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 CYCLOSPORINE (A) AQUEOUS (HUMAN) 0.5% OPHTHALMIC 10 ML, 5 ML; CYCLOSPORINE (A) AQUEOUS PF… Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 TRIAMCINOLONE ACETONIDE 4MG/ML (0.4MG/0.1ML) INJECTABLE 10 ML 5 ML TRIAMCINOLONE… Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 CYCLOPENT/PHENYLEPH/TROPICAMIDE/PROPARACAINE 2%/2.5%/1%/0.5% OPHTHALMIC 5 ML (1 PRODUCT) Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 TOBRAMYCIN 1.4% (14MG/ML) OPHTHALMIC 15 ML 3 ML 7 ML; TOBRAMYCIN SOLUTION** 0.3%… Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 LIDOCAINE HCL/BUPIVACAINE HCL PF 1%/0.375% OPHTHALMIC 30 ML 48 ML 60 ML 90 ML; LIDOCAINE… Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 POVIDONE-IODINE/LIDOCAINE/TETRACAINE 4.6%/4%/0.5% OPHTHALMIC 30 ML (1 PRODUCT) Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 ESTRADIOL 25MG PELLETS 1 PELLET, 15 PEL, 15 PELLET, 2 PELLET, 2 TAB, 3 PELLET, 4 PELLET,… Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 BACLOFEN, P.F. (WITH 0.9% P.F. NORMAL SALINE) 2,000MCG/ML (2MG/ML) INTRATHECAL 40 ML;… Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 THERACYS, (BCG VACCINE) LIVE W/DILUENT** 81MG INJECTABLE 1 VIAL 1 VIALS 12 VIAL 12 VIALS… Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 BEVACIZUMAB & DXM, SDPF - (0.06ML SYRINGE, 31G, 5/16") 25MG/100MG/ML INJECTABLE 0.72 ML;… Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 ASCORBIC ACID (BEET SOURCE) 500MG/ML INJECTABLE 100 ML, 150 ML, 200 ML, 250 ML, 300 ML,… Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 GANCYCLOVIR, SDPF - (30G, 1/2" SYRINGE) 20MG/ML INJECTABLE 1 ML (1 PRODUCT) Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE 100 ML 80 ML (2 DIFFERENT PRODUCTS) Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class III August 22, 2012 Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01%, Body Oil, 4 fl. oz. (118.28mL ), Rx… Subpotent; fluocinolone acetonide Hill Dermaceuticals, Inc. Terminated
Class II August 22, 2012 SELENIUM 200MCG/ML INJECTABLE 150 ML 30 ML 60 ML (3 DIFFERENT PRODUCTS) Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 MEYERS COCKTAIL INJECTABLE 30 ML; MEYERS COCKTAIL (DR. MORENO) INJECTABLE 90 ML; MEYERS… Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated
Class II August 22, 2012 BUPIVACAINE/LIDOCAINE 0.11% / 0.44% INJECTABLE 150 ML (1 PRODUCT) Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between… Franck's Lab Inc., d.b.a. Franck's Compounding Lab Terminated