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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 August 21, 2013 Gentamicin Sulfate Irrigation, compounded by Pallimed Solutions Pharmacy, Woburn, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Pallimed Solutions Terminated
Class II August 21, 2013 REEVA (triclosan) Antibacterial Hand Soap and Dishwashing Liquid, Green Apple, 0.10%, 24… Microbial Contamination of a Non-Sterile Products: Product was found to be contaminated with the bacteria, Sarcina… Showline Automotive Products, Inc. dba US Soaps Mfg. Company Terminated
Class II August 21, 2013 Nandrolone Decanoate Injectable, compounded by Pallimed Solutions Pharmacy, Woburn, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Pallimed Solutions Terminated
Class II August 21, 2013 (No Brand) First Aid Kit, 326 Piece Kit. Product labeling reads in part: BE SMART GET… CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated due to failure in… Total Resources Intl Terminated
Class II August 21, 2013 BiMix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Pallimed Solutions Terminated
Class II August 21, 2013 Cyclosporine Ophthalmic, compounded by Pallimed Solutions Pharmacy, Woburn, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Pallimed Solutions Terminated
Class II August 21, 2013 Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution), USP, 37%… Presence of foreign substance: One lot of the product may contain black foreign particles Bracco Diagnostics Inc Terminated
Class II August 21, 2013 Quadmix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Pallimed Solutions Terminated
Class II August 21, 2013 Tacrolimus Ophthalmic, Pallimed Solutions Pharmacy, Woburn, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Pallimed Solutions Terminated
Class II August 21, 2013 Hydroxyprogesterone CAPR.(G.S.), compounded by Pallimed Solutions Pharmacy, Woburn MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Pallimed Solutions Terminated
Class II August 21, 2013 Atropine Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Pallimed Solutions Terminated
Class II August 21, 2013 HCG Chorionic Gonadotropin, compounded by Pallimed Solutions Pharmacy, Woburn, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Pallimed Solutions Terminated
Class II August 21, 2013 Testosterone Cypionate Injection,compounded by Pallimed Solutions Pharmacy, Woburn, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Pallimed Solutions Terminated
Class II August 21, 2013 Verapamil Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Pallimed Solutions Terminated
Class II August 21, 2013 Buprenorphine HCl Veterinary Injection, compounded by Pallimed Solutions Pharmacy,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Pallimed Solutions Terminated
Class II August 21, 2013 Trimix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Pallimed Solutions Terminated
Class II August 21, 2013 Cidofovir Opthalmic Solution, compounded by Pallimed Solutions Pharmacy, Woburn, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Pallimed Solutions Terminated
Class II August 21, 2013 Methylcobalamin PF, compounded by Pallimed Solutions Pharmacy, Woburn, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Pallimed Solutions Terminated
Class II August 21, 2013 MIC with B6 and B12, compounded by Pallimed Solutions Pharmacy, Woburn, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Pallimed Solutions Terminated
Class II August 21, 2013 Acetylcysteine Ophthalmic Solution, compounded by Pallimed Solutions Pharmacy, Woburn, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Pallimed Solutions Terminated
Class III August 21, 2013 buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carton, 10… Failed Stability Specifications; out of specification results at the 9 month stability time point for color,… American Health Packaging Terminated
Class III August 21, 2013 Clobetasol Propionate Cream, USP, 0.05%, 15 grams, Rx only, Hi-Tech PHARMACAL label,… Labeling: Label Mix-up; some cartons labeled as Clobetasol Propionate Cream USP contain tubes labeled as Clobetasol… Hi-Tech Pharmacal Co., Inc. Terminated
Class II August 21, 2013 DMSO Aqueous Irrigation 50%, compounded by Pallimed Solutions Pharmacy, Woburn, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Pallimed Solutions Terminated
Class II August 21, 2013 Testosterone Cypionate/Testosterone Enanthate Injection, compounded by Pallimed Solutions… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Pallimed Solutions Terminated
Class II August 21, 2013 3M Tekk Brand Industrial/Construction First Aid Kit, Total Resources Int'l Walnut, CA… CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated due to failure in… Total Resources Intl Terminated
Class II August 21, 2013 Vancomycin Ophthalmic PF, compounded by Pallimed Solutions Pharmacy, Wobrun, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Pallimed Solutions Terminated
Class II August 21, 2013 Belladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10) and 5000… Presence of Foreign Substance: black specks comprised of degraded organic material found on tablets West-Ward Pharmaceutical Corp. Terminated
Class II August 21, 2013 Alprostadil IN NS Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Pallimed Solutions Terminated
Class II August 21, 2013 Bacteriostatic Water for Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Pallimed Solutions Terminated
Class II August 21, 2013 Medi-First Brand First Aid Kit, MEDI-FIRST 61 Piece Kit, Home, Workplace Travel, Sport,… CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated due to failure in… Total Resources Intl Terminated
Class II August 21, 2013 Testosterone Cypionate/Propionate Injection, compounded by Pallimed Solutions Pharmacy,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Pallimed Solutions Terminated
Class II August 21, 2013 Dexamethasone PF, compounded by Pallimed Solutions Pharmacy, Woburn, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Pallimed Solutions Terminated
Class II August 21, 2013 Diazepam Injectable, compounded by Pallimed Solutions Pharmacy, Woburn, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control… Pallimed Solutions Terminated
Class II August 21, 2013 Rifadin (rifampin) capsules, USP, 150 mg, 100-count capsules per bottle, Manufactured by:… Subpotent Drug: During review of retain samples, the manufacturer observed low fill in some capsules, which was related… Sanofi-Synthelabo Terminated
Class II August 21, 2013 Ranitidine Hydrochloride Tablets, USP, 150 mg, OTC, a) Equate brand Maximum Strength Acid… Microbial Contamination of Non-Sterile Products: A lot of raw material used in the manufacture of Ranitidine was… Dr. Reddy's Laboratories, Inc. Terminated
Class III August 21, 2013 Prednisone Prednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablets per… Labeling: Missing Label; missing label on blister card Boehringer Ingelheim Roxane Inc Terminated
Class II August 21, 2013 propofol Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 mL, Single patient infusion… Presence of Particulate Matter; single visible particulate was identified during a retain sample inspection identified… Hospira Inc. Terminated
Class II August 14, 2013 Zolpidem Tartrate Tablets 5 mg, 10 tablets per blister, 10 blisters per carton, 100… Unit Dose Mispackaging: This recall event is due to a random undetected packaging issue which could increase the… American Health Packaging Terminated
Class I August 14, 2013 Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package… Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution. Apotex Corp. Terminated
Class II August 14, 2013 Latanoprost Ophthalmic Solution, 0.005% (125 mcg/2.5 mL), 2.5 mL bottle, Rx only,… Lack of Assurance of Sterility: Failed at expiry for Preservative Effectiveness Test (PET), therefore the product may… Apotex Inc Terminated
Class I August 14, 2013 0.9% Sodium Chloride Injection, USP, 1000 mL flexible container, Rx only, Hospira, Inc.,… Presence of Particulate Matter: reports of small grey/brown particles found in the primary container identified as… Hospira Inc. Terminated
Class II August 14, 2013 Excedrin Migraine (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a)… Defective container: products are packaged in pouches which may not have been fully sealed Novartis Consumer Health Terminated
Class II August 14, 2013 VersaPharm Incorporated, Ethambutol Hydrochloride Tablets, USP 400 mg 60 tablets, Rx… Discoloration: Ethambutol HCl Tablets 400 mg is being recalled due to a Out of Specification result for description… West-Ward Pharmaceutical Corp. Terminated
Class I August 14, 2013 Lightning ROD capsules, 500 mg/capsule, packaged in 3-count bottles (UPC 6 89076 20257 2). Marketed Without An Approved NDA/ANDA: Lightning Rod capsules are being recalled because FDA analysis found it to… Chang Kwung Products Terminated
Class II August 14, 2013 Rifadin, Rifampin capsules, 150 mg, packaged in 30-count bottle, Rx only, Mfd. for… Subpotent drug: low fill volume in some of the capsules Sanofi US Terminated
Class III August 14, 2013 Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg, packaged… Contraceptive tablets out of sequence: Contraceptive tablets out of sequence: Introvale (levonorgestrel and ethinyl… Sandoz Incorporated Terminated
Class II August 14, 2013 Terazosin Hydrochloride Capsules,10 mg, 100-count bottle, Rx only, Manufactured for Teva… Labeling -label error on declared strength: unopened, sealed bottle of Terazosin Hydrochloride (HCl) 10mg Capsules… Teva Pharmaceuticals USA, Inc. Terminated
Class I August 14, 2013 Reumofan Plus, 30-count tablets per bottle, distriubted by Reumofan Plus USA, LLC and… Marketed without an approved NDA/ANDA: Product may contain undeclared active pharmaceutical ingredients Diclofenac… Reumofan Plus USA Terminated
Class II August 14, 2013 Parsel Plus (reference US product: Excedrin Tension Headache) (Acetaminophen 500 mg and… Defective container: products are packaged in pouches which may not have been fully sealed Novartis Consumer Health Terminated
Class II August 14, 2013 Lisinopril Tablets, USP, 2.5 mg, Rx only, packaged in a) 100-count bottles (NDC… Failed Impurities/Degradation Specifications: Out of Specification results for Individual Other Unknown Related… West-Ward Pharmaceutical Corp. Terminated
Class I August 14, 2013 Lightning ROD capsules, 550 mg/capsule, packaged in 12-count bottles (UPC 6 89076 20297… Marketed Without An Approved NDA/ANDA: Lightning Rod capsules are being recalled because FDA analysis found it to… Chang Kwung Products Terminated
Class III August 14, 2013 BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per… Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification… Actavis Inc Terminated
Class II August 14, 2013 Excedrin Extra Strength (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65… Defective container: products are packaged in pouches which may not have been fully sealed Novartis Consumer Health Terminated
Class I August 14, 2013 Methotrexate Injection, USP, Preservative-Free, 1 g/40 mL (25 mg/mL), 40 mL Single Dose… Presence of Particulate Matter: Found during examination of retention samples. Sandoz Incorporated Terminated
Class II August 14, 2013 MERREM I.V. (meropenem for injection), 1 g meropenem equivalent, 30 mL vial, Rx only, Mfd… Presence of Precipitate; potential for incomplete constitution upon addition of diluent. AstraZeneca Pharmaceuticals LP Terminated
Class II August 14, 2013 No Doz, Max Strength (200 mg caffeine) caplets, 2-count caplets per pouch, Distributed by… Defective container: products are packaged in pouches which may not have been fully sealed Novartis Consumer Health Terminated
Class I August 14, 2013 Warfarin Sodium Tablets, USP 2 mg, Rx Only, 1000 Tablets per bottle, Manufactured by:… Failed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who discovered that 3 tablets… Zydus Pharmaceuticals USA Inc Terminated
Class II August 14, 2013 ONDANSETRON Ondansetron Injection, USP, 4mg/2mL, (2mg/ml), 2mL single-dose Fliptop Vial, Rx only,… Presence of Particulate; lot being recalled as a precaution due to the discovery of 2 particles found in a lot which… Hospira, Inc. Terminated
Class III August 14, 2013 TUMS, Antacid/Calcium Supplement, ULTRA Strength 1000, Assorted Berries, 72 Chewable… Presence of Foreign Tablets/Capsules: Product labeled TUMS Ultra Assorted Berries 1000mg Chewable tables, may contain… GlaxoSmithKline, LLC. Terminated
Class II August 14, 2013 Methylphenidate Hydrochloride Extended-Release Capsules (LA), 30 mg, 100 count bottle, Rx… Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained… Teva Pharmaceuticals USA, Inc. Terminated
Class II August 14, 2013 Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 count bottle, Rx… Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained… Teva Pharmaceuticals USA, Inc. Terminated
Class II August 14, 2013 Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 count bottle, Rx… Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained… Teva Pharmaceuticals USA, Inc. Terminated
Class II August 7, 2013 Olanzapine Tablets, USP, 10 mg, Rx Only, 30 tablets per bottle, Mfd for: Prasco… Defective Container; This action is being taken as a precautionary measure due to the product being re-packaged in the… Torrent Pharma Inc Terminated
Class II August 7, 2013 Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL, Rx Only. Manufactured by… Failed Impurity/Degradation Specification; "Related Compound C" Actavis South Atlantic LLC Terminated
Class II August 7, 2013 DayQuil Sinex DayTime Sinus Relief (acetaminophen 325 mg and phenylephrine HCl 5 mg)… Unit Dose Mispackaging: Product packaging defect which could result in code date smearing, incomplete blister card… Procter & Gamble Co Terminated
Class II August 7, 2013 Belladonna Alkaloids/PB (Belladonna Alkaloids / Phenobarbital) Tablets Phenobarbital USP… Presence of Foriegn Substance:The manufacturer, West-ward Pharmaceutical, recalled product because of the presence of… Physicians Total Care, Inc. Terminated
Class II August 7, 2013 Enablex (darifenacin) Extended Release Tablet, 15 mg per tablet. Physician Sample 7… Failed Impurities/Degradation Specifications: unspecified degradation product Warner Chilcott US LLC Terminated
Class I August 7, 2013 Night Bullet Capsules, supplied in 1 count packets, produced by Green Planet Inc,… Marketed Without an Approved NDA/ANDA; product contains analogues of sildenafil and tadalafil which are active… Green Planet Inc Terminated
Class II August 7, 2013 DIANEAL LOW CALCIUM WITH DEXTROSE DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL… Defective Container: There is a potential for frangible components to be broken, resulting in a leak at the port when… Baxter Healthcare Corp. Terminated
Class II July 31, 2013 AmBisome (amphotericin B) liposome for injection, 50mg vial, single use vial, For… Lack of Assurance of Sterility; Astellas Pharma US, Inc. is performing a voluntary recall on certain lots of AmBisome… Astellas Pharma US Inc Terminated
Class II July 31, 2013 VIVITROL VIVITROL (naltrexone for extended-release injectable suspension) a) 380 mg vial NDC… Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during… Alkermes, Inc. Terminated
Class I July 31, 2013 Magnesium Sulfate 2 grams in Dextrose 5% for Injection, in 50 mL Plastic Infusion Bags,… Non-Sterility; mold contamination Med Prep Consulting, Inc. Terminated
Class II July 31, 2013 West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC… Presence of Foreign Substance: Belladonna Alkaloids with Phenobarbital Tablets with black specks comprised of degraded… West-Ward Pharmaceutical Corp. Terminated
Class II July 31, 2013 West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC… Cross contamination with other products: Belladonna Alkaloids with Phenobarbital Tablets contained a trace amount of… West-Ward Pharmaceutical Corp. Terminated
Class II July 31, 2013 Oxygen, Compressed USP UN1072 Medical Gas supplied in a) 682 litres and b)165 litres… Failed impurities/degradation specifications: Purity readings for oxygen were out of specification. Oklahoma Respiratory Care Inc Terminated
Class II July 31, 2013 All Compounded Products, packaged in plastic infusion bags, devices, syringes and glass… Lack of Assurance of Sterility; potential for mold contamination Med Prep Consulting, Inc. Terminated
Class III July 31, 2013 LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, Shade MEDIUM… Subpotent Drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may… Max Huber Research Labs, Inc. Terminated
Class III July 31, 2013 ALCOHOL FREE ANTISEPTIC (cetylpyridinium chloride) Mouth Rinse, 0.07%, mint, 33.8 FL OZ… Microbial Contamination of Non-Sterile Products: This product is being recalled because a stability sample was found to… Vi-Jon, Inc. Terminated
Class III July 31, 2013 LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, Shade LIGHT… Subpotent Drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may… Max Huber Research Labs, Inc. Terminated
Class III July 31, 2013 Oxycodone and Acetaminophen Capsules, USP 5mg/500 mg, packaged in a)100-count bottle (NDC… Subpotent drug: Two lots of Oxycodone and Acetaminophen Capsules, USP 5/500 mg are being recalled due to low out of… Watson Laboratories Inc Terminated
Class III July 31, 2013 LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, Shade DARK… Subpotent drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may… Max Huber Research Labs, Inc. Terminated
Class I July 31, 2013 Mitosol (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use (NDC 49771-002-01),… Non-Sterility: one or more components of the kit have been found to be contaminated with yeast. Mobius Therapeutics LLC Terminated
Class II July 31, 2013 SODIUM CHLORIDE Sodium Chloride Injection, USP, 0.9%, 20 mL Single-dose Fliptop Plastic Vial, packaged in… Presence of Particulate Matter: Confirmed customer report of visible particulate in the form of an orange or rust… Hospira Inc. Terminated
Class III July 31, 2013 Pharmalucence Kit for the Preparation of Technetium Tc 99m Sestamibi Injection for… Presence of Particulate Matter; particulate found in retain samples Pharmalucence, Inc. Terminated
Class II July 31, 2013 Diclofenac Sodium and Misoprostol Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, 60-count bottle,… Failed Tablet/Capsule Specifications: Broken tablets Watson Laboratories, Inc.-(Actavis) - Florida Terminated
Class II July 31, 2013 AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infusion Only,… Lack of Sterility Assurance; During a routine simulation of the manufacturing of AmBisome, a bacterial contamination… Gilead Sciences, Inc. Terminated
Class II July 24, 2013 QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packaged and… Failed Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was… American Health Packaging Terminated
Class II July 24, 2013 Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP2 Grade, packaged… Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. Church & Dwight Inc Terminated
Class II July 24, 2013 Estarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, 3X28 tablets… Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets. Sandoz Incorporated Terminated
Class III July 24, 2013 Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingredient, Rx… Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test… Bayer HealthCare Pharmaceuticals Inc. Terminated
Class II July 24, 2013 Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx… Subpotent Drug; 15-month stability test station Fresenius Kabi USA, LLC Terminated
Class II July 24, 2013 Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP1 Grade, packaged… Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. Church & Dwight Inc Terminated
Class II July 24, 2013 Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP3 Grade, packaged… Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. Church & Dwight Inc Terminated
Class II July 24, 2013 Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, Sodium Bicarbonate U.S.P. No. 4… Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. Church & Dwight Inc Terminated
Class I July 24, 2013 Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package… Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution. Apotex Corp. Terminated
Class II July 24, 2013 Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP5 Grade, packaged… Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. Church & Dwight Inc Terminated
Class III July 24, 2013 Amoxicillin Amoxicillin for Oral Suspension, USP 200 mg/5 mL, a) 75 mL bottle NDC 0093-4160-78 and b)… Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner… Teva Pharmaceuticals USA, Inc. Terminated
Class III July 17, 2013 Junel Junel(TM) Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous… Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected… Teva Pharmaceuticals USA, Inc. Terminated
Class II July 17, 2013 Deslorelin 15 mg vial, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Papaverine 40 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Pentosan 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Metabolase Forte Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Yohimbine 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Phenylephrine 1 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Progesterone 100 mg/ml in Olive Oil Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Idoxuridine 0.1% Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Stanozolol (50 mg/ml and 100 mg/ml) Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Pento-Gluc 200 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Atropine Sulfate 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Dexpanthenol 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Voriconazole 5% Ophthalmic drop compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Vitamin 15 (HEMO15) Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 L-ArGiNINE 200 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Tacrolimus (0.02% and 0.03%) drops, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Calcium Gluconate 23%, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Praziquantel 56.8mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Guanabenz 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Dextrose 50% Solution, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Bi mix, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Methylcobalamin 25 mg/ml Inj and 5000 mcg/ml Injection, compounded by Olympia Pharmacy,… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Medroxyprogesterone 150 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Vitamin A/D3/E Olive Oil Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Aminocaproic Acid 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Sermorelin/GHRP 3 mg/3 mg vial, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Metabolase Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Diclazuril 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Doxapram 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Betamethasone Sodium Phosphate 12 mg/ml Injection, compounded by Olympia Pharmacy,… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Beta Alanine 100 mg/ml / l-carnosine 100 mg/ml Injection, compounded by Olympia Pharmacy,… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Iodine 20 mg Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 BNP/Dexamethasone Eye Ointment, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Quadmix, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Medetomidine 2 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Methylprednisolone Acetate 80 mg/ml Injection, compounded by Olympia, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Metoclopramide 5 mg/ml Injection,compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Enrofloxacin 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Sodium Iodide 20% Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Phentolamine 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Estradiol Cypionate 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Taurine 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Meloxicam 5 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Sodium Salicylate 40% Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Disodium EDTA Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Miconazole 3% Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Alprostadil 2000 mcg/ml, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Methylcobalamin P 10/ml Creatine 40 mg/ml / Arginine 100 mg/ml Injection, compounded by… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Progesterone EO 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Cre-O-Pan Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Trimix, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Lisinopril 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 PEN-DEX-CHLOR Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Potassium Phosphate Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Naproxen 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Xylazine 300 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Gentamicin Sulfate 80 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 HCG 125iu/0.25ml (550iu/ml), 3500iu and 10,000iu, compounded by Olympia Pharmacy,… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Detomidine 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Ketamine 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Buprenorphine 0.3 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Betamethasone Phosphate/Acetate 6 mg/ml Injection, compounded by Olympia Pharmacy,… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 HACC 270.1 Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Detomidine w/Xylazine 100 mg/mg Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Fluphenazine 25 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Glutathione 200 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Vitamin B-Buildup Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Polidocanol (0.75%, 1%, 3%, and 10%) Injection, compounded by Olympia Pharmacy, Orlando,… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Estradiol Cypionate 2 mg/ml Test Cyp 50 mg/ml Injection, compounded by Olympia Pharmacy,… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Gentamicin 80 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Dexamethasone Sodium Phosphate 6 mg/ml Injection, compounded by Olympia Pharmacy,… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Aminophylline 2.5% Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Tripelennamine 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Hippiron 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Phenylbutazone 200 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Testosterone Cypionate (100 mg/ml & 200 mg/ml) Injection, compounded by Olympia Pharmacy,… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Vitamin B12 (3000 mcg/ml & 5000 mcg/ml) Injection, compounded by Olympia Pharmacy,… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Adenosine-Mono-Phosphate Injection, 200 mg/ml, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Acetyl-D-Glucosamine w/Chondroitin 200 mg/ml, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 MICC (Methionine, Inositol, Choline, Cyanocobalamin, Chromium) Inj and MICC 25/50/330… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Atipamezole 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Ketoprofen Solution 10% Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Chlorpromazine HCL 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Clenbuterol 0.03mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Furosemide 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Gentamicin 0.3% Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Aminocaproic Acid 0.5mg/ml Injection,compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Altrenogest 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Gentamicin 300 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Phenobarbital 62. 5mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Guanabenz 8 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Acepromazine 25 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Amikacin Sulfate 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Ceftiofur GM vial 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Methylcobalamin 1 mg/ml / Folic Acid 2.5 mg/ml Injection, compounded by Olympia Pharmacy,… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Vitamin B12 Cyanocobalamin 5000 mcg Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Sodium Tetradecyl Sulfate (0.125%, 1%, 2.5%, 3%, and 4%) Injection, compounded by Olympia… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Caco/Copper 6. 2 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Neomycin / Polymyxin / Dexamethasone Ophthalmic Drops, compounded by Olympia Pharmacy,… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Lipotoxin Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Gaba 50 mg/Mag Sulfate 50 mg/Taurine/Theanine 50 mg/ml Injection, compounded by Olympia… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 ITPP 50 mg/ml DMG 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Cal-Phos 1000 Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Diphenhydramine 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Oxytocin 20 units/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy Ongoing
Class II July 17, 2013 Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose… Crystallization; crystallized nimodipine Sun Pharmaceutical Industries Inc. Terminated
Class III July 17, 2013 Folic Acid Injection, USP, 5 mg/mL, For IM, IV or SC Use, 10 mL, Multiple Dose Vial, Rx… Failed Impurities/Degradation Specification Fresenius Kabi USA, LLC Terminated
Class III July 17, 2013 Camila (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets… Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected… Teva Pharmaceuticals USA, Inc. Terminated
Class III July 17, 2013 Errin (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each,… Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected… Teva Pharmaceuticals USA, Inc. Terminated
Class III July 17, 2013 Lessina(R) (Levonorgestrel and ethinyl estradiol tablets, USP) 0.1 mg/0.02 mg, 28 day… Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected… Teva Pharmaceuticals USA, Inc. Terminated
Class II July 17, 2013 Benztropine Mesylate Injection, USP, 2 mg/2 mL (1 mg/1 mL), 2 mL Single Dose Vial, Rx… Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with… Fresenius Kabi USA, LLC Terminated
Class III July 17, 2013 Nicardipine Hydrochloride Nicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use vials, Rx… Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative… West-ward Pharmaceutical Corp. Terminated
Class III July 17, 2013 Balziva(TM) (norethindrone and ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 28 day… Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected… Teva Pharmaceuticals USA, Inc. Terminated
Class III July 17, 2013 Jolessa(R) (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 91 day… Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected… Teva Pharmaceuticals USA, Inc. Terminated
Class II July 17, 2013 GENTAMICIN SULFATE Gentamicin Sulfate Injection USP 80 mg/2 mL(40 mg/mL as Gentamicin), 2 mL Single-dose… Presence of Particulate Matter: visible particles were identified floating in the primary container. Hospira Inc. Terminated
Class II July 10, 2013 Test Cyp 50 mg-estradiol blend 22 mg, Clinical Specialties Compounding Pharmacy, 318… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Test cyp 25 mg-estradiol cyp 7 mg/ml, Clinical Specialties Compounding Pharmacy, 318… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Test Cyp 100 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta,… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Test cyp 35 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta,… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Tetracaine(buffered) 0.25% solution, Clinical Specialties Compounding Pharmacy, 318… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Acetylcysteine 2 % Solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road,… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Diazepam 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Estradiol Valerate 30 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road,… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Test Cyp 10 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta,… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Hydroxyprogesterone 250 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Acetylcysteine 20 % solution, 100 ml bottle, Clinical Specialties Compounding Pharmacy,… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Test Cyp 50 mg-estradiol cyp 2 mg/ml, Clinical Specialties Compounding Pharmacy, 318… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 HCG 2000 units/ml, 30 mL syringe, Clinical Specialties Compounding Pharmacy, 318 Baston… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Methylcobalamin 12.5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road,… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Ophthalmic dilation gel (MAR), Clinical Specialties Compounding Pharmacy, 318 Baston… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Phenylephrine-cyclopentolate, Clinical Specialties Compounding Pharmacy, 318 Baston Road,… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Sodium Chloride (23.4%), Clinical Specialties Compounding Pharmacy, 318 Baston Road,… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Medroxyprogesterone 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road,… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Progesterone 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road,… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Lidocaine Hydrochloride and 5% Dextrose Injection, USP, 2g VIAFLEX Plus Plastic… Lack of Assurance of Sterilty: Specific lot numbers of these products have been identified for potential administration… Baxter Healthcare Corp. Terminated
Class II July 10, 2013 Gentamicin buffered 36.4 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Estradiol Valerate 20 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road,… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Ophthalmic dilation gel, Clinical Specialties Compounding Pharmacy, 318 Baston Road,… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Mitomycin (modified) 0.02% solution, Clinical Specialties Compounding Pharmacy, 318… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy Terminated
Class III July 10, 2013 Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/2.5 mg, 1… Failed Dissolution Specifications: Pfizer Inc. is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate… Pfizer Inc. Terminated
Class III July 10, 2013 Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/5.0 mg, 1… Failed Dissolution Specifications: Pfizer Inc. (Pfizer) is recalling PREMPRO (conjugated estrogens/medroxyprogesterone… Pfizer Inc. Terminated
Class II July 10, 2013 Laser ophthalmic drops, 12 mL bottle, Clinical Specialties Compounding Pharmacy, 318… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Acetylcysteine 10 % Solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road,… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Test cyp 75 mg-estradiol cyp 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Test Cyp 50 mg-estradiol cyp 2 mg/ml, Clinical Specialties Compounding Pharmacy, 318… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Cyclosporine 2% ophthalmic, Clinical Specialties Compounding Pharmacy, 318 Baston Road,… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Cataract drops, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Test Cyp 250 mg-lidocaine 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Test cyp 25 mg-Estradiol cyp 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Methylcobalamin 1250 mcg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road,… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 Test Cyp 200 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta,… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy Terminated
Class II July 10, 2013 HCG 1000 units/ml, 30 mL syringe, Clinical Specialties Compounding Pharmacy, 318 Baston… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Clinical Specialties Compounding Pharmacy Terminated