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
| Class | Reported | Product | Reason | Firm | Status |
|---|---|---|---|---|---|
| Class I | May 7, 2014 | TrophAmine (10% Amino Acid Injection), 500 mL Container, Rx Only, Catalog No. S9341-SS,… | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible… | B. Braun Medical Inc | Terminated |
| Class I | May 7, 2014 | Cefoxitin and Dextrose Cefoxitin for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Container, Catalog… | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible… | B. Braun Medical Inc | Terminated |
| Class II | May 7, 2014 | Phosphatidylcholine Solution for Injection, 50 mg/ mL, 50 mL Vial, Rx Only, Not for… | Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial. | John W Hollis Inc | Terminated |
| Class II | May 7, 2014 | Polidocanol 3% Solution, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pharmacy, 110… | Presence of Particulate Matter | John W Hollis Inc | Terminated |
| Class III | May 7, 2014 | Papaverine 60 mg, Phentolamine 4 mg, and Atropine 0.3 mg Solution, 10 mL Vial, Rx Only.… | Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial. | John W Hollis Inc | Terminated |
| Class I | May 7, 2014 | Human Chorionic Gonadotropin, EP (HCG) in 5 mu. 2 mu, and 1 mu packages, For use and… | Labeling: Label Error on Declared Strength; Firm states that erroneous potency information was found on the label. | Medisca Inc. | Terminated |
| Class I | May 7, 2014 | 6.9% FreAmine HBC (Amino Acid Injection), partial fill container 750 mL in a 1000 mL… | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible… | B. Braun Medical Inc | Terminated |
| Class III | May 7, 2014 | Glytone Acne, acne treatment facial cleanser, 2% Salicylic Acid, 200 mL/6.7 FL Oz Bottle,… | Failed Stability Specifications: Out of specification results for viscosity in one lot of Glytone Acne Treatment Facial… | Genesis Pharmaceutical, Inc. | Terminated |
| Class I | May 7, 2014 | Adipotrim XT, New Powerful Formula, 30 rapid release capsules per bottle, Dietary… | Marketed Without an Approved NDA/ANDA: FDA lab results found undeclared API Fluoxetine in this dietary supplement. | Deseo Rebajar | Terminated |
| Class I | May 7, 2014 | Ceftriaxone for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Container, Catalog… | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible… | B. Braun Medical Inc | Terminated |
| Class III | May 7, 2014 | Maximum Strength/Non-Drowsy Tussin DM Adult Maximum Strength, Cough Cold,… | Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. | Aaron Industries Inc | Terminated |
| Class I | May 7, 2014 | 0.9 % Sodium Chloride Injection USP, 1000 mL, Catalog No. S4000-SS, Rx Only, Sterile,… | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible… | B. Braun Medical Inc | Terminated |
| Class II | May 7, 2014 | Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, packaged in a) 30-count… | Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution… | Caraco Pharmaceutical Laboratories, Ltd. | Terminated |
| Class III | May 7, 2014 | Children's Triacting Night Time Cold & Cough with PE (diphenhydramine hcl and… | Presence of Precipitate: Small amounts of diphenydramine and mannitol precipitated out of solution. | P&L Developments, LLC | Terminated |
| Class II | May 7, 2014 | Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, packaged in a) 30-count… | Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution… | Caraco Pharmaceutical Laboratories, Ltd. | Terminated |
| Class III | May 7, 2014 | Polidocanol 1% Solution, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pharmacy, 110… | Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial. | John W Hollis Inc | Terminated |
| Class I | May 7, 2014 | Hyperlyte CR (Multi-Electrolyte Concentrate), 20 mL/dose, 250 mL Container, Catalog No.… | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible… | B. Braun Medical Inc | Terminated |
| Class I | May 7, 2014 | SODIUM CHLORIDE 0.9 % Sodium Chloride Injection USP in PAB 50 mL partial fill in 100 mL PAB Container,… | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible… | B. Braun Medical Inc | Terminated |
| Class I | May 7, 2014 | 15% Amino Acids Injection PBP Glass, 1000 mL, Catalog No. S3200-SS, Pharmacy Bulk… | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible… | B. Braun Medical Inc | Terminated |
| Class I | May 7, 2014 | ProcalAmine (3% Amino Acid and 3% Glycerin Injection with Electrolytes) 1000 mL… | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible… | B. Braun Medical Inc | Terminated |
| Class III | May 7, 2014 | Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Apotex Inc.,… | Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point. | Apotex Inc. | Terminated |
| Class I | May 7, 2014 | Cefazolin Sodium Cefazolin for Injection USP and Dextrose Injection USP, 2 g in Duplex, 50 mL Container,… | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible… | B. Braun Medical Inc | Terminated |
| Class II | May 7, 2014 | Fluoxetine Fluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-648-01), b)… | Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor. | Teva Pharmaceuticals USA | Terminated |
| Class II | May 7, 2014 | Fluoxetine Fluoxetine Capsules USP, 10 mg, 100-count bottles, Rx only, Manufactured in Poland By:… | Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor. | Teva Pharmaceuticals USA | Terminated |
| Class I | May 7, 2014 | Cefazolin Sodium Cefazolin for Injection USP and Dextrose Injections USP, 1 g in Duplex, 50 mL Container,… | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible… | B. Braun Medical Inc | Terminated |
| Class II | May 7, 2014 | Fluoxetine Fluoxetine Capsules, USP, 20 mg, 30-count bottles, Rx only, Distributed by: Wal-Mart,… | Chemical Contamination: The recalling firm received notice that their supplier is recalling capsules due to complaints… | Legacy Pharmaceutical Packaging | Terminated |
| Class II | May 7, 2014 | Lupron Depot Lupron Depot (leuprolide acetate for depot suspension) Single Dose Administration Kit… | Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle… | AbbVie Inc | Terminated |
| Class II | May 7, 2014 | Sevoflurane Sevoflurane, USP (Inhalation Anesthetic), Rx Only, 250 mL Amber Bottle. Manufactured By:… | Failed pH Specifications: product was too acidic. | Piramal Critical Care, Inc. | Terminated |
| Class I | May 7, 2014 | CEFEPIME HYDROCHLORIDE AND DEXTROSE Cefepime for Injections USP and Dextrose Injection USP, 1 g in Duplex, 50 mL Container,… | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible… | B. Braun Medical Inc | Terminated |
| Class II | May 7, 2014 | Lupron Depot Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit… | Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle… | AbbVie Inc | Terminated |
| Class II | May 7, 2014 | Lupron Depot Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit… | Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle… | AbbVie Inc | Terminated |
| Class III | May 7, 2014 | Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun… | Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for… | Caraco Pharmaceutical Laboratories, Ltd. | Terminated |
| Class II | May 7, 2014 | Sodium Chloride 0.9% Sodium Chloride Irrigation, USP, 1000 mL,Not for Injection, Manufactured by Baxter… | Presence of Particulate Matter: Nylon fibers found in a bottle of 0.9% sodium chloride for irrigation. | Baxter Healthcare Corp. | Terminated |
| Class II | May 7, 2014 | Lupron Depot-PED LUPRON DEPOT-PED (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit… | Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle… | AbbVie Inc | Terminated |
| Class I | May 7, 2014 | DIANEAL LOW CALCIUM WITH DEXTROSE Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II… | Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch. | Baxter Healthcare Corp. | Terminated |
| Class II | May 7, 2014 | Lupron Depot Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit… | Defective Delivery System: Some Lupron Depot Kits may containin a syringe with a potentially defective LuproLoc needle… | AbbVie Inc | Terminated |
| Class III | May 7, 2014 | Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle, OTC,… | Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for… | Caraco Pharmaceutical Laboratories, Ltd. | Terminated |
| Class I | May 7, 2014 | Lidocaine Hydrochloride Lidocaine HCl Injection, USP, 2%, 20 mg per mL, packaged in 5-mL single-dose vials, 10… | Presence of Particulate Matter- Confimed customer complaint of particulates embedded in glass container and in contact… | Hospira Inc. | Terminated |
| Class I | April 30, 2014 | Glycopyrrolate (MDV) 0.2 MG/ML Injectable, 5 mL Vials, Sterile Serum Vials/Sterile… | Non-Sterility: One lot of Glycopyrrolate solution for injection was found to be contaminated with Bacillus… | Brookfield Prescription Center Inc | Terminated |
| Class I | April 30, 2014 | RezzRX capsules, Single Blister Pack and 20 count bottle, Distributed By: Fossil Fuel… | Marketed Without an Approved NDA/ANDA: Fossil Fuel Products, is recalling RezzRX due to undeclared… | Fossil Fuel Products, LLC | Terminated |
| Class III | April 30, 2014 | NICORETTE Nicorette (nicotine polacrilex) Lozenges Mini, 2 mg, Original Flavor, 20 Lozenge, 27… | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline | Terminated |
| Class I | April 30, 2014 | XIYOUJI QINGZHI CAPSULE, 300mg, 20 count box | Marketed without an Approved NDA/ANDA: Products found to contain undeclared sibutramine. Sibutramine was removed from… | Dolphin Intertrade Corporation | Terminated |
| Class III | April 30, 2014 | Nicotine polacrilex lozenge, 4 mg, Cherry Flavor, 72 count cartons, 81 count cartons, and… | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline | Terminated |
| Class II | April 30, 2014 | Potassium Chloride for Inj. Concentrate, USP, 40 mEq (2 mEq/mL), 20 mL Single-dose… | Presence of Particulate; red and black particulate within the solution and embedded within the plastic vial identified… | Hospira Inc. | Terminated |
| Class III | April 30, 2014 | Nicotine polacrilex lozenge, 2 mg, Mint Flavor, 81 count cartons and 189 count cartons.… | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline | Terminated |
| Class III | April 30, 2014 | Nicotine polacrilex lozenge, 4 mg, Mint Flavor, 81 Lozenge and 189 Lozenge Vials. OTC.… | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline | Terminated |
| Class III | April 30, 2014 | NICORETTE Nicotine polacrilex lozenge, 4 mg, Original Flavor, 72 count cartons, 81 count cartons,… | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline | Terminated |
| Class II | April 30, 2014 | Loratadine and Pseudoephedrine Sulfate Non-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongestant, Pseudoephedrine… | Defective Container: An unacceptable level of blister defects have been identified in Loratadine and Pseudoephedrine… | Ohm Laboratories, Inc. | Terminated |
| Class III | April 30, 2014 | NICORETTE Nicorette (nicotine polacrilex) Lozenges Mini, 4 mg, Original Flavor, 20 Lozenge and 81… | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline | Terminated |
| Class II | April 30, 2014 | Tikosyn¿ (dofetilide) 500 mcg (0.5mg) capsules, 60-count bottle, Rx only Pfizer Labs,… | Presence of Foriegn Tablets/Capsules: A single Tikosyn¿ (dofetilide) 250 mcg capsule was discovered in one bottle of… | Pfizer Inc. | Terminated |
| Class III | April 30, 2014 | Day Time Cold & Flu, Multi-Symptom, Non-Drowsy, Acetaminophen, Dextromethorphan HBr,… | Subpotent Drug: Phenylephrine component is subpotent. | P&L Developments, LLC | Terminated |
| Class III | April 30, 2014 | Oxandrolone Tablets, USP, 10 mg, Rx Only, C-III, 60-count bottle, Manufactured for:… | Labeling: Missing Label; Three cases of product (total of 36 bottles) were packaged without the primary label on the… | Upsher Smith Laboratories, Inc. | Terminated |
| Class III | April 30, 2014 | Nicorette Lozenge, Nicoderm CQ, and Nicorette Gum nicotine polacrilex combination.… | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline | Terminated |
| Class III | April 30, 2014 | Nicorette Lozenge and NicoDerm CQ, nicotine polacrilex system. 189 2mg Mint Flavored… | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline | Terminated |
| Class I | April 30, 2014 | JaDera, 100% Natural Weight Loss Supplement, capsules, 30 count bottle | Marketed without an Approved NDA/ANDA: Products found to contain undeclared sibutramine. Sibutramine was removed from… | Dolphin Intertrade Corporation | Terminated |
| Class III | April 30, 2014 | NICORETTE Nicotine polacrilex lozenge, 2 mg, Original Flavor, 72 count cartons, 81 count cartons,… | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline | Terminated |
| Class III | April 30, 2014 | Nicotine polacrilex lozenge, 2 mg, Cherry Flavor, 72 count vials, 81 count vials, and 108… | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline | Terminated |
| Class I | April 30, 2014 | VPRIV¿ (velaglucerase alfa for injection) , Lyophilized Powder, 400 Units/vial, Rx Only.… | Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate. | Shire Human Genetic Therapies, Inc. | Terminated |
| Class I | April 23, 2014 | Slim Expert softgel capsules Dietary Supplement. One month supply/ 30 softgels. 1 softgel… | Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine | B @ B Trade Inc. | Terminated |
| Class I | April 23, 2014 | Lidiy capsules Dietary Supplement. Each bottle contains 30 capsules. | Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine | B @ B Trade Inc. | Terminated |
| Class I | April 23, 2014 | Slim Fortune capsules Dietary Supplement. Each bottle contains 30 capsules. | Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine | B @ B Trade Inc. | Terminated |
| Class I | April 23, 2014 | Virilis Pro, 450mg/capsule, Packaged in a 1 and 2 capsule blister packs and 10 capsule… | Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredients found in some… | Haute Health, LLC | Terminated |
| Class I | April 23, 2014 | Prolifta Dietary Supplement Prolifta, 400mg/capsule, Packaged in 1 and 2 capsule blister… | Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of an active ingredient found in some… | Haute Health, LLC | Terminated |
| Class I | April 23, 2014 | PHUK Sexual Enhancement Ultimate Pleasure, 400mg/capsule, packaged in 1 and 2 capsule… | Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredients found in some… | Haute Health, LLC | Terminated |
| Class I | April 23, 2014 | Lidocaine Hydrochloride 1% Lidocaine HCl Injection, USP, 10 mg/mL, NDC 0409-4276-01, Hospira, Inc., Lake Forest,… | Presence of Particulate Matter: Oxidized stainless steel found in vial of 1% Lidocaine Hydrochloride Injection, USP. | Hospira, Inc. | Terminated |
| Class II | April 16, 2014 | Pleo Not PORTABLE SIPS, 6X, 10 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made… | Penicillin Cross Contamination | Terra-Medica Inc. | Terminated |
| Class II | April 16, 2014 | Pleo Stolo DROPS 6X, 10ml Bottle; Homeopathic Anti-Inflammatory Medicine, OTC Only. Made… | Penicillin Cross Contamination | Terra-Medica Inc. | Terminated |
| Class II | April 16, 2014 | Pleo Ex SUPPOSITORIES 3X, 10 Suppository Packages; Homeopathic Antifungal Medicine, OTC… | Penicillin Cross Contamination | Terra-Medica Inc. | Terminated |
| Class I | April 16, 2014 | Dream Body Slimming Capsule (Chinese bitter orange 24%, Cassia Seed 18%, Aloe 16%, Lotus… | Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and . Sibutramine is not currently… | Slim Beauty USA | Terminated |
| Class II | April 16, 2014 | Pleo Not CAPSULES 4X, 20 Tablet Cartons, Oral Homeopathic Fever Reducer/ Cough… | Penicillin Cross Contamination | Terra-Medica Inc. | Terminated |
| Class II | April 16, 2014 | Pleo Ex DROPS 5X, 10 ml bottles, Homeopathic Antifungal Medicine, OTC Only. Made in… | Penicillin Cross Contamination | Terra-Medica Inc. | Terminated |
| Class II | April 16, 2014 | Pleo Not SUPPOSITORIES 3X, 10 Suppository Cartons, Homeopathic Medicine, OTC Only. Made… | Penicillin Cross Contamination | Terra-Medica Inc. | Terminated |
| Class II | April 16, 2014 | Pleo Fort TABLETS 5X, 20 Tablet Carton, Homeopathic Digestive Aid Medicine, OTC Only.… | Penicillin Cross Contamination | Terra-Medica Inc. | Terminated |
| Class II | April 16, 2014 | Sodium Bicarbonate 8.4%, a) 10 mL, b) 20 mL, and c) 22 mL units, Not for Dispensing, For… | Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of… | Zions RX Formulations Services LLC dba RX Formuations Serv. | Terminated |
| Class II | April 16, 2014 | Ranitidine Tablets USP, 150 mg, 500-count bottles, Rx only, Manufactured by: Shasun… | Presence of Foreign Tablets/Capsules: Recall is due to a pharmacist complaint of a "foreign material", identified as… | Glenmark Generics Inc., USA | Terminated |
| Class II | April 16, 2014 | Pleo Fort PORTABLE SIPS 5X, 10 x 1 mL Carton. Oral Homeopathic Medicine, OTC Only. Made… | Penicillin Cross Contamination. | Terra-Medica Inc. | Terminated |
| Class I | April 16, 2014 | Black Ant, 4600 mg x 4. Product is packaged in a small green box with gold lettering on… | Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined the Vicerex product… | American Lifestyle.Com | Terminated |
| Class I | April 16, 2014 | Dr. Ming's Chinese Capsule (Ginger 50 mg, Camellia Sinensis 50 mg, Malus Domestica 50 mg,… | Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Sibutramine and… | Slim Beauty USA | Terminated |
| Class I | April 16, 2014 | Calcium Gluconate 10% for Injection, SDV 100 mL SDV, PF, Not for Dispensing, For Hospital… | Non-Sterility: RX Formulation initiated this recall due to a report of microbial contamination found in Calcium… | Zions RX Formulations Services LLC dba RX Formuations Serv. | Terminated |
| Class I | April 16, 2014 | Magic Slim capsules (Ling Zhi, Ebony, Fox-nut, Tuckahoe, Seman Pruni, Dioscoreae, Wheat… | Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Marketed… | Slim Beauty USA | Terminated |
| Class II | April 16, 2014 | Pleo Quent DROPS 5X, 10 mL Bottles, Oral Homeopathic Medicine, OTC Only. Made in Germany… | Penicillin Cross Contamination | Terra-Medica Inc. | Terminated |
| Class II | April 16, 2014 | Pleo Not DROPS, 5X, 10 mL Bottles, Oral Homeopathic Medicine, OTC Only. Made in Germany,… | Penicillin Cross Contamination | Terra-Medica Inc. | Terminated |
| Class II | April 16, 2014 | Pleo Quent PORTABLE SIPS 5X, 10 x 1 ml Cartons, Oral Homeopathic Medicine, OTC Only. Made… | Penicillin Cross Contamination | Terra-Medica Inc. | Terminated |
| Class I | April 16, 2014 | Vicerex A Powerful And Fast Acting Male Sexual Enhancer, 10 capsules per box, Dietary… | Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined the Vicerex product… | American Lifestyle.Com | Terminated |
| Class III | April 16, 2014 | Demerol, meperidine HCL Inj. USP, 25 mg/0.5 mL (50 mg/mL), 0.5 mL ampoules, Rx only, NDC… | Labeling; Missing label; ampoules are missing the immediate container label | Hospira Inc. | Terminated |
| Class II | April 16, 2014 | Pleo Not OINTMENT 3X, 30 g Tube, Topical Homeopathic Medicine, OTC Only. Made in Germany,… | Penicillin Cross Contamination | Terra-Medica Inc. | Terminated |
| Class II | April 16, 2014 | Vitamin B-12 injections, a) 1 mL and b) 30 mL units, Not for Dispensing, For Hospital… | Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of… | Zions RX Formulations Services LLC dba RX Formuations Serv. | Terminated |
| Class II | April 16, 2014 | Pleo Nota- Quent DROPS 5X, 10 mL Bottles, Homeopathic Medicine, OTC Only. Made in… | Penicillin Cross Contamination | Terra-Medica Inc. | Terminated |
| Class II | April 16, 2014 | Magnesium Sulfate 10gm in 250mL Lactated Ringers Bags, Not For Dispensing, For Hospital… | Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of… | Zions RX Formulations Services LLC dba RX Formuations Serv. | Terminated |
| Class II | April 16, 2014 | Pleo Quent CAPSULES 4X, 20 Capsule Cartons, Oral Homeopathic Medicine, OTC Only. Made in… | Penicillin Cross Contamination | Terra-Medica Inc. | Terminated |
| Class II | April 16, 2014 | Pleo Not PORTABLE SIPS 7X,10 x 1 mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in… | Penicillin Cross Contamination | Terra-Medica Inc. | Terminated |
| Class II | April 16, 2014 | Potassium Phosphates 4.4mEq/3mM/mL Vials, Not for Dispensing, For Hospital Administration… | Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of… | Zions RX Formulations Services LLC dba RX Formuations Serv. | Terminated |
| Class II | April 16, 2014 | Pleo Ex PORTABLE SIPS 5X, 10 x 1 mL, Oral Homeopathic Medicine, OTC Only. Made in… | Penicillin Cross Contamination | Terra-Medica Inc. | Terminated |
| Class II | April 16, 2014 | Oxytocin 30 Units in 500mL Sodium Chloride 0.9% Bags, Not for Dispensing, For Hospital… | Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of… | Zions RX Formulations Services LLC dba RX Formuations Serv. | Terminated |
| Class II | April 16, 2014 | Pleo Fort SUPPOSITORIES 3X, 10 Suppository Carton, Homeopathic Digestive Aid Medicine,… | Penicillin Cross Contamination | Terra-Medica Inc. | Terminated |
| Class II | April 16, 2014 | Pleo Not TABLETS 5X, 20 Tablet Cartons, Oral Homeopathic Medicine, OTC Only. Made in… | Penicillin Cross Contamination | Terra-Medica Inc. | Terminated |
| Class II | April 16, 2014 | Pleo Not PORTABLE SIPS, 5X, 10 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made… | Penicillin Cross Contamination | Terra-Medica Inc. | Terminated |
| Class II | April 16, 2014 | etomidate injection, USP, 2 mg/mL, packaged in a) 20 mg/10 mL (2 mg/mL), 10 mL Single… | Presence of Particulate Matter: Potential for small black particles to be present in individual vials, the potential… | Agila Specialties Private Ltd. | Terminated |
| Class II | April 16, 2014 | Pleo Quent SUPPOSITORIES 3X, 10 Suppository Cartons, Oral Homeopathic Medicine, OTC Only.… | Penicillin Cross Contamination | Terra-Medica Inc. | Terminated |
| Class II | April 16, 2014 | Bupivacaine 3%, 300 mL units, Not for Dispensing, For Hospital Administration Only, Rx… | Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of… | Zions RX Formulations Services LLC dba RX Formuations Serv. | Terminated |
| Class II | April 16, 2014 | Pleo-Fort DROPS 5X, 10ml bottle, Homeopathic Digestive Aid Medicine, OTC Only. Made in… | Penicillin Cross Contamination | Terra-Medica Inc. | Terminated |
| Class II | April 16, 2014 | Pleo Fort CAPSULES 4X, 20 Capsule Cartons Homeopathic Digestive Aid Medicine, OTC Only.… | Penicillin Cross Contamination | Terra-Medica Inc. | Terminated |
| Class III | April 16, 2014 | Spiriva Spiriva HandiHaler (tiotropium bromide inhalation powder), Do Not Swallow Spiriva… | Defective Delivery System: Potential for dose delivery out of specification due to interation of the drug product… | Boehringer Ingelheim Roxane Inc | Terminated |
| Class III | April 16, 2014 | Ritalin HCl (methylphenidate HCl) USP, 20 mg, 100 tablets per Bottle, Rx only, Mfd. by:… | Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for… | Novartis Pharmaceuticals Corp. | Terminated |
| Class III | April 16, 2014 | Ritalin HCl (methylphenidate HCl) USP, 10 mg, 100 tablets per Bottle, Rx only, Mfd. by:… | Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for… | Novartis Pharmaceuticals Corp. | Terminated |
| Class II | April 9, 2014 | HydrOXYzine HCl Tablets, USP 25 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC.… | Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source. | American Health Packaging | Terminated |
| Class II | April 9, 2014 | HydrOXYzine HCl Tablets, USP 50 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC.… | Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source. | American Health Packaging | Terminated |
| Class II | April 9, 2014 | Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 30 Capsules per Bottle,… | Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR… | Teva Pharmaceuticals USA | Terminated |
| Class III | April 9, 2014 | QVAR¿ (beclomethasone dipropionate HFA), C4 INHALATION AEROSOL in Aluminum Cylinders,… | Failed Impurity/Degradation Specification; for 17-BMP at the 9 and 18 month stability time point | Teva Pharmaceuticals USA | Terminated |
| Class II | April 9, 2014 | Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx Only, 60 capsules per Bottle,… | Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR… | Teva Pharmaceuticals USA | Terminated |
| Class II | April 9, 2014 | Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 30 Capsules per Bottle,… | Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR… | Teva Pharmaceuticals USA | Terminated |
| Class III | April 9, 2014 | Suprax, Cefixime for Oral Suspension USP, 500 mg/5 ml, 20 mL (when reconstituted), Rx… | Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month… | Lupin Pharmaceuticals Inc. | Terminated |
| Class III | April 9, 2014 | Suprax, Cefixime for Oral Suspension USP 500 mg/5 ml, 10mL (when reconstituted), Rx only,… | Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month… | Lupin Pharmaceuticals Inc. | Terminated |
| Class III | April 9, 2014 | Tivicay Tivicay (dolutegravir) Tablets 50 mg, 30 Tablet Bottles, Rx Only. Manufactured for: ViiV… | Cross Contamination with Other Products: Product contains Promacta (eltrombopag). | Viiv Healthcare Company | Terminated |
| Class III | April 2, 2014 | SETON PHARMACEUTICALS Fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl.oz., Rx… | Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine… | Hill Dermaceuticals, Inc. | Terminated |
| Class III | April 2, 2014 | Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only… | Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine… | Hill Dermaceuticals, Inc. | Terminated |
| Class III | April 2, 2014 | SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Topical Oil (Body Oil), 4 fl.oz., Rx… | Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine… | Hill Dermaceuticals, Inc. | Terminated |
| Class III | April 2, 2014 | DermOtic Oil (fluocinolone acetonide) 0.01% Ear Drops, 20 mL bottle, Rx only Manufactured… | Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine… | Hill Dermaceuticals, Inc. | Terminated |
| Class III | April 2, 2014 | Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl. oz., Rx… | Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine… | Hill Dermaceuticals, Inc. | Terminated |
| Class III | April 2, 2014 | SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Oil EAR DROPS, 20 ml, Rx only… | Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine… | Hill Dermaceuticals, Inc. | Terminated |
| Class III | April 2, 2014 | ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), 20 ml, Rx… | Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine… | Hill Dermaceuticals, Inc. | Terminated |
| Class III | April 2, 2014 | DERMA-SMOOTHE/FS ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body… | Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine… | Hill Dermaceuticals, Inc. | Terminated |
| Class III | April 2, 2014 | DERMA-SMOOTHE/FS ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% (Scalp Oil), 4… | Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine… | Hill Dermaceuticals, Inc. | Terminated |
| Class II | March 26, 2014 | Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil, 1 ml injectable solution, in 3 ml… | Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatures during shipping | RX South LLC DBA RX3 Pharmacy | Terminated |
| Class I | March 26, 2014 | Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language) | Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that the products was… | Fabscout Entertainment, Inc | Terminated |
| Class II | March 26, 2014 | Guaifenesin USP, 50 Kg Drums, CAS No. 93-14-1, Reg. No. 05436, Caution: For… | Presence of Foreign Matter: Guaifenesin API powder is being recalled due to the possibility that the product contains… | Traxx International Corp | Terminated |
| Class III | March 26, 2014 | Venlafaxine Hydrochloride, Extended Release Capsules, 150 mg, UD-100 Tablets per Box (10… | Failed Dissolution Specification: Out of Specification dissolution results at 12 month interval. | McKesson Packaging Services | Terminated |
| Class I | March 26, 2014 | Silver Sword capsules, 180 mg, 16-count clamshell tin, UPC 1 234658 970128 12345… | Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that the products was… | Fabscout Entertainment, Inc | Terminated |
| Class III | March 26, 2014 | Advil PM Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg) 120 count bottle,… | Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate. | Pfizer Us Pharmaceutical Group | Terminated |
| Class II | March 26, 2014 | Perrigo, Clindamycin Palmitate Hydrochloride for Oral Solution, USP, 75mg/5mL, 100 ml,… | Presence of Particulate Matter Perrigo is recalling seven lots of Clindamycin Palmitate Hydrochloride for Oral Solution… | Paddock Laboratories, LLC | Terminated |
| Class II | March 26, 2014 | Daytrana Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours… | Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients… | Noven Pharmaceuticals, Inc. | Terminated |
| Class II | March 26, 2014 | Daytrana Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours… | Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients… | Noven Pharmaceuticals, Inc. | Terminated |
| Class I | March 26, 2014 | Dextrose 5% Dextrose Injection, USP, 100 mL Single dose VIAFLEX plastic containers, Rx only,… | Presence of Paticulate Matter; Baxter is issuing a voluntary recall for these IV solutions due to particulate matter… | Baxter Healthcare Corp. | Terminated |
| Class I | March 26, 2014 | CLINIMIX Clinimix 5/15 sulfite-free (5% Amino Acid in 15% Dextrose) Injection, 2000 mL CLARITY… | Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose. | Baxter Healthcare Corp. | Terminated |
| Class I | March 26, 2014 | CLINIMIX E Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with… | Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose. | Baxter Healthcare Corp. | Terminated |
| Class I | March 26, 2014 | SODIUM CHLORIDE 0.9% Sodium Chloride Injection, USP, packaged in a) 50 mL Single dose VIAFLEX plastic… | Presence of Particulate Matter: Baxter is issuing a voluntary recall for these IV solutions due to particulate matter… | Baxter Healthcare Corp. | Terminated |
| Class I | March 26, 2014 | Marcaine Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative… | Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the… | Hospira Inc. | Terminated |
| Class I | March 26, 2014 | CLINIMIX E Clinimix 4.25/25 sulfite-free (4.25% Amino Acid in 25% Dextrose) Injection, 1000… | Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose. | Baxter Healthcare Corp. | Terminated |
| Class I | March 19, 2014 | BEST Slim, Dietary Supplement, 100% Natural Weight Loss Pill, 40 Pills per bottle,… | Marketed without an Approved NDA/ANDA: Product contains an undeclared drug, sibutramine, making it an unapproved new… | CTV Best Group | Terminated |
| Class III | March 19, 2014 | Carisoprodol Tablets, USP, 350 mg, unit dose blister packages of 100 tablets (10 cards of… | Failed Impurity/degradation Specification | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) | Terminated |
| Class I | March 19, 2014 | Dextrose* Vial In Sterile Water, 50%, 50 mL Single Dose Vial, Rx only, Specialty Medicine… | Non-Sterility: 50% dextrose is being recalled after particulate matter, later identified as mold, was found floating in… | Specialty Medicine Compounding Pharmacy, P.C. | Terminated |
| Class III | March 19, 2014 | Photofrin (porfimer sodium) for Injection, 75 mg Single Use Flip-Top Vial, Rx Only.… | Stability Data Does Not Support Expiry: Printed expiration date should be Nov 2013 rather than Nov 2014. | Pinnacle Biologics Inc | Terminated |
| Class III | March 19, 2014 | Triamcinolone Acetonide Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E. Fougera &… | Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%. | Fougera Pharmaceuticals Inc. | Terminated |
| Class II | March 19, 2014 | Alprazolam Alprazolam 1 mg Tablets, USP, 500 count Bottle, Rx Only , C IV, Manufactured by: Actavis… | Failed Tablet/Capsule Specifications: Complaints were received for significant tablet erosion for Alprazolam 1 mg. | Actavis Elizabeth LLC | Terminated |
| Class II | March 12, 2014 | Renacidin Irrigation | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | 5-Fluorouracil 1% ophthal | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | Prostaglandin all combinations | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | Cyano B-12 (Cmpd) 1000mcg/ml | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | Cyano B-12 p-f 1000mcg/ml | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | Cyanocobalamin 100mcg/ml injection | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class I | March 12, 2014 | B-50 capsules, Healthy Life Chemistry By Purity First, packaged in 100 count bottles,… | Marketed without an Approved NDA/ANDA; product found to contain methasterone and dimethazine which are steroid and/or… | Mira Health Products Ltd. | Terminated |
| Class I | March 12, 2014 | Super-DMZ Rx 2.0 Capsules, 60 count bottles, Dietary Supplement, Lean muscle mass,… | Marketed without an Approved NDA/ANDA; product contains the steroid ingredient 2,… | Mira Health Products Ltd. | Terminated |
| Class II | March 12, 2014 | Lidocaine 4% Urethral Gel | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | Voriconazole 1% opthal | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | Triamcinolone Acetonide 3mg/ml | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | Folic acid (pf) 10mg/cc inj | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | Idoxuridine 0.1% Ophthalmic | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | AMP/M-B12/Pyridox/Methionine Inositol | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | Voriconazole 0.5mg/ml | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | EDTA 3% ophthalmic | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class III | March 12, 2014 | Tussin CF Adult Maximum Strength Multi-Symptom Cold liquid (dextromethorphan HBr 10 mg,… | Presence of Precipitate: Recall is due to complaints of a white substance, confirmed as Guaifenesin, an active… | Aaron Industries Inc | Terminated |
| Class II | March 12, 2014 | Voriconazole 0.5mg/ml | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | Acetylcysteine 10% ophthalmic | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | Vit A (olive oil) 0.1% opth. | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | Terbutaline/Ipratropium 0.5mg/2.5ml | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | Vitamin D (Ergocalciferol) 800 u/ml | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | Bleomycin Sulfate 1unit/ml | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | Novarel (IM) | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | Hydroxocobalamin inj. | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | Bladder Instillation | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | Pyridoxine (p-f) 100mg/ml | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | Testosterone Cypionate 100mg/ml | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | Estradiol Cypionate 2mg/cc testosterone cypionoate 50mg | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class I | March 12, 2014 | METHA-DROL Extreme capsules, packaged as 60 capsules per bottle Pro-Anabolic Mass Stack… | Marketed without an Approved NDA/ANDA; product found to contain dimethazine which is a steroid and/or steroid-like drug… | Mira Health Products Ltd. | Terminated |
| Class II | March 12, 2014 | Ethanol 20% ophthal. | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | Papaverine 1nj 30mg/ml | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | Gentamycin 80mg/1000cc 0.9% NS | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | Vancomycin (fortified) 25mg/ml opth | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | Glutathione Inhalation 200mg/5ml | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | a) Walgreens Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 14 capsules… | Microbial Contamination of Non-Sterile Products: Out-of-specification results for microbial count were observed at the… | Dr. Reddy's Laboratories, Inc. | Terminated |
| Class II | March 12, 2014 | Methotrexate Intraocular 400mcg 0.1cc | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | Glutathione 1.25%/Ascorbic 1.25%/DMSO 6.25% | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | L-Glutathione inhalation | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | Dexamethasone phosphate 24mg/ml inj. | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | Tacrolimus (H20-based) 0.03% ophth. | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | Methylcobalamin | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | Glutathione 6%/ascorbic 1%/DMSO 6.25% | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | Testosterone Cypionate 200mg/ml | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | Tetracaine 0.5% ophth. | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | Hydroxyprogesterone Caproate | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | Sodium Bicarbonate 8.4% inj. | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | Tacrolimus 0.02% opth. (H20-based) | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | Dexamethosone/Tobramycin pf 0.1%/0.3% ophthalmic | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | Dexamethasone (pf) 0.05 % opth. | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | Papaverine 12mg/phent 1mg/Pros 9mcq/ml | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | Scopolamine 0.25 opth. | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | 5-Fluorouracil pf in methocel 1% opthal | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to… | Natures Pharmacy & Compounding Center | Terminated |
| Class II | March 12, 2014 | Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle, Rx… | CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved material: the… | Teva Pharmaceuticals USA | Terminated |
| Class II | March 12, 2014 | 0.9% Sodium Chloride Injection, USP 1000 mL Flexible Container, Rx Only, Hospira, Inc.,… | Lack of Assurance of Sterility:Solution leaking through the port cover of the primary container, which was identified… | Hospira Inc. | Terminated |
| Class II | March 12, 2014 | Heparin Sodium Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV… | Subpotent; 18 month time point | Fresenius Kabi USA, LLC | Terminated |
| Class II | March 12, 2014 | hydroxyzine pamoate Teva Hydroxyzine Pamoate Capsules, USP, 100 mg, 100- count bottle,Rx only, Distributed by… | CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 100 mg were manufactured using an unapproved material: API was… | Teva Pharmaceuticals USA | Terminated |
| Class II | March 12, 2014 | hydroxyzine pamoate Teva Hydroxyzine Pamoate Capsules, USP, 25 mg, 100- count bottle, Rx Only,Distributed by… | CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 25 mg were manufactured using an unapproved material: API was… | Teva Pharmaceuticals USA | Terminated |
| Class II | March 12, 2014 | Bupivacaine Hydrochloride Bupivacaine HCl Inj. USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative Free Vial, Rx… | Presence of Particulate Matter: Confirmed customer report of visible particulate embedded in the glass vial. | Hospira Inc. | Terminated |
| Class II | March 12, 2014 | Alprazolam Extended-Release Tablets, USP, 3 mg, 60-count tablets per bottle, Rx only,… | Failed Dissolution Specifications: Product did not meet specification requirements for dissolution. | Actavis Elizabeth LLC | Terminated |
| Class II | March 12, 2014 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Teva Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and… | CGMP Deviations: Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate… | Teva Pharmaceuticals USA | Terminated |
| Class III | March 5, 2014 | Gelnique (oxybutynin chloride) Gel 10%, 100 mg in 1 g sachet, for topical use only.… | Subpotent Drug: Drug potency was compromised during shipment. | Actavis | Terminated |
| Class II | March 5, 2014 | Clonazepam Tablets, USP 2 mg 100 tablets Manufactured by: Actavis Elizabeth LLC 200… | Subpotent Drug: During routine stability testing one tablet was found with tablet weight below specification. | Actavis Elizabeth LLC | Terminated |
| Class III | March 5, 2014 | Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg)… | Presence of Foreign Substance: Red Silicone Rubber Particulates are Present in Drug. | Gilead Sciences, Inc. | Terminated |
| Class II | March 5, 2014 | ATORVASTATIN CALCIUM Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manufactured… | Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg… | Ranbaxy Inc. | Terminated |
| Class II | March 5, 2014 | Metformin Hydrochloride Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx only, 500 count bottles,… | Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER | Caraco Pharmaceutical Laboratories, Ltd. | Terminated |
| Class III | February 19, 2014 | VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), 450 mL bottle, Rx Only.… | Failed Stability Testing: This product is below specification for preservative content. | Bracco Diagnostics Inc | Terminated |
| Class II | February 19, 2014 | Trelstar (triptorelin pamoate) for Injectable Suspension Single-Dose Vial (NDC… | Labeling: Label Error On Declared Strength: Trelstar 11.25 mg labeled carton/kit contained a vial labeled as 3.75 mg… | Actavis Inc | Terminated |
| Class II | February 19, 2014 | Levothyroxine Sodium Tablets, USP, 200 mcg, 100-count bottle, Rx only, Distributed by… | Subpotent Drug: Assay results obtained during stability testing for Levothyroxine Sodium Tablets, USP were below… | Mylan Pharmaceuticals Inc. | Terminated |
| Class II | February 19, 2014 | Oxcarbazepine Oxcarbazepine Tablets, 300 mg, 100 tablet bottles, Rx Only. Distributed by: Caraco… | Failed Tablet Specifications: Broken Tablets Present. | Caraco Pharmaceutical Laboratories Ltd. | Terminated |
| Class II | February 19, 2014 | Diclofenac Sodium and Misoprostol Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle,… | Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples. | Watson Laboratories, Inc.-(Actavis) - Florida | Terminated |
| Class II | February 12, 2014 | Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML | Microbial Contamination of Non-Sterile Products: Fusion Pharmaceuticals is recalling the Dicopanol FusePaq Kit due to… | Fusion Pharmaceuticals, LLC | Terminated |
| Class II | February 12, 2014 | Hydralazine HCL Tablets, USP, 50 mg in a single blister package, Rx only, Manufactured in… | Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for… | Teva Pharmaceuticals USA | Terminated |
| Class III | February 12, 2014 | Ofloxacin Ophthalmic Solution, USP 0.3%, 5mL, (NDC 16571-130-50). The products are… | Defective Container: Stability samples of both products were noted to have some white solid product residue, identified… | PACK Pharmaceuticals, LLC | Terminated |
| Class II | February 12, 2014 | Hydralazine HCL Tablets, USP, 25 mg in a single blister package, Manufactured in Czech… | Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for… | Teva Pharmaceuticals USA | Terminated |
| Class III | February 12, 2014 | Ofloxacin Ophthalmic Solution, USP 0.3%, 10mL, (NDC 16571-130-11). The products are… | Defective Container: Stability samples of both products were noted to have some white solid product residue, identified… | PACK Pharmaceuticals, LLC | Terminated |
| Class II | February 12, 2014 | HEALTH & BEYOND DR. LARRY'S Tranquility DIETARY SUPPLEMENT 30 Capsules Manufactured for:… | Marketed Without an Approved NDA/ANDA; product found to contain Doxepin (an antidepressant) and Chlorpromazine (an… | Health & Beyond | Terminated |
| Class III | February 12, 2014 | Glipizide XL (glipizide) extended release tablets, 5 mg , 500 count bottles, Rx only,… | Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr timepoint, 18 month… | Greenstone Llc | Terminated |
| Class II | February 12, 2014 | Cornea Coat, Hydroxypropylmethylcellulose, 1.5ml Syringe, Rx Only. Manufactured by:… | Marketed without an Approved NDA/ANDA. | Insight Instruments, Inc. | Terminated |
| Class III | February 12, 2014 | Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 10mL, (NDC 16571-140-10). The… | Defective Container: Stability samples of both products were noted to have some white solid product residue, identified… | PACK Pharmaceuticals, LLC | Terminated |
| Class II | February 12, 2014 | FAMILY wellness Triple Antibiotic Ointment. NET WT 1 OZ (28 g), OTC, DISTRIBUTED BY:… | Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental… | Faria Limited LLC dba Sheffield Pharmaceuticals | Terminated |
| Class II | February 12, 2014 | CHILDREN'S IBUPROFEN, ORAL SUSPENSION, 200 mg/10mL cup BERRY FLAVOR, ALCOHOL FREE, MFG:… | CGMP Deviation: Discoloration; Product fails specification for appearance/color. A complaint was received regarding an… | Central Shared Services dba Parallon | Terminated |
| Class II | February 12, 2014 | Dollar General Triple Antibiotic Ointment; NET WT 1 OZ (28 g), OTC, DISTRIBUTED BY… | Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental… | Faria Limited LLC dba Sheffield Pharmaceuticals | Terminated |
| Class II | February 12, 2014 | Pyridostigmine Bromide Tablets USP, 60 mg, 100 count bottle, Rx only, Manufactured and… | Failed Dissolution Specification: Corepharma Inc. is recalling Pyridostigmine Bromide Tablets USP 60 mg due to an out… | Corepharma LLC | Terminated |
| Class III | February 12, 2014 | Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 5mL, (NDC 16571-140-50). The… | Defective Container: Stability samples of both products were noted to have some white solid product residue, identified… | PACK Pharmaceuticals, LLC | Terminated |
| Class III | February 12, 2014 | Namenda XR (memantine HCl), sample pack, 28 mg, extended release capsules, packaged in… | Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing. | Forest Pharmaceuticals Inc | Terminated |
| Class II | February 12, 2014 | The firm is recalling all lots of sterile products compounded by the pharmacy that are… | Lack of Assurance of Sterility: The recall is being initiated due to the lack of sterility assurance and concerns… | Apothecure, Inc | Terminated |
| Class III | February 12, 2014 | Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 5mL, (NDC 16571-141-50). The… | Defective Container: Stability samples of both products were noted to have some white solid product residue, identified… | PACK Pharmaceuticals, LLC | Terminated |
| Class III | February 12, 2014 | Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 10mL, (NDC 16571-141-10). The… | Defective Container: Stability samples of both products were noted to have some white solid product residue, identified… | PACK Pharmaceuticals, LLC | Terminated |
| Class II | February 12, 2014 | Valacyclovir Hydrochloride Tablets, 1 g, 30 count bottle, Rx only manufactured in Israel… | Presence of Foreign Tablets/Capsules: Potential of Pravastatin tablet fragments in bottles of Valacyclovir 1 gm Tablets. | Teva Pharmaceuticals USA, Inc. | Terminated |
| Class III | February 12, 2014 | Glucotrol XL (glipizide) extended release tablets, 5 mg, 100 count bottles, Rx only,… | Failed Dissolution Specification; 8 hr stability timepoint | Pfizer Inc. | Terminated |
| Class II | February 12, 2014 | Metoprolol succinate Dr. Reddy's Metoprolol Succinate Extended-Release Tablets USP, 50 mg 100 tablets Rx Only… | Failed Dissolution Specification; 12-Month stability interval. | Dr. Reddy's Laboratories, Inc. | Terminated |
| Class III | February 12, 2014 | Namenda XR (memantine HCl), 7 mg extended release capsules, 30-count bottle, Rx only,… | Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing. | Forest Pharmaceuticals Inc | Terminated |
| Class III | February 12, 2014 | Namenda XR (memantine HCl), titration pack (7 mg, 14 mg, 21 mg and 28 mg) extended… | Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing. | Forest Pharmaceuticals Inc | Terminated |
| Class II | February 12, 2014 | Dr. Sheffield Triple Antibiotic Ointment, OTC a) 0.33 oz (9g) (NDC 11527-162-47); b) 1 oz… | Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental… | Faria Limited LLC dba Sheffield Pharmaceuticals | Terminated |
| Class I | February 12, 2014 | Nitroglycerin In Dextrose 50 mg Nitroglycerin in 5% Dextrose Injection (200 mcg/mL), 250 mL glass containers,… | Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber from the… | Baxter Healthcare Corp. | Terminated |
| Class I | February 12, 2014 | CEFEPIME HYDROCHLORIDE AND DEXTROSE Cefepime for Injection USP and Dextrose Injection USP, in Duplex Drug Delivery System, 1… | Presence of Particulate Matter: The 1g Cefepime for Injection USP and Dextrose Injection USP lot has been found to… | B. Braun Medical Inc | Terminated |
| Class II | February 12, 2014 | Diclofenac Sodium and Misoprostol Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, Rx only,… | Failed Tablet/Capsule Specifications: Broken tablets | Actavis Inc | Terminated |
| Class II | February 5, 2014 | ROHTO Dry Eye, hydra, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3… | Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief… | The Mentholatum Co. | Terminated |
| Class II | February 5, 2014 | ROHTO Cooling Eye Drops, Itch Relief, Soothes Itch & Burn, relief, Astringent, Lubricant,… | Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief… | The Mentholatum Co. | Terminated |
| Class II | February 5, 2014 | ROHTO Redness Relief, ice, Redness Reliever, Lubricant, Astringent Eye Drops, Sterile,… | Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief… | The Mentholatum Co. | Terminated |
| Class II | February 5, 2014 | ROHTO Redness Relief, arctic, Redness Reliever, Lubricant Eye Drops, Sterile, Net. Wt.… | Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief… | The Mentholatum Co. | Terminated |
| Class II | February 5, 2014 | Mercuroclear Antiseptic Anesthetic First Aid Helps prevent infection and relieves pain… | Microbial Contamination of Non-Sterile Product(s): The product was found to be contaminated with Bulkholderia sp. | Humco Holding Group, Inc | Terminated |
| Class II | February 5, 2014 | Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII, 10 mg/ 660 mg, 100 count… | Failed Tablet/Capsule Specifications; Product contains broken tablets. | Watson Laboratories Inc | Terminated |
| Class I | February 5, 2014 | Sermorelin/GHRP-6, 3 mg/3 mg, 5 mL vial, Stock # 21740, Compounded by NuVision Pharmacy,… | Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assurance and concerns… | NuVision Pharmacy, Inc. | Terminated |
| Class I | February 5, 2014 | Hydravax High Potency Diuretic Weight Loss Solution, Pharmaceutical Grade, 45 capsules… | Marketed Without an Approved NDA/ANDA; this product is being recalled for containing an undeclared diuretic called… | IQ Formulations, LLC | Terminated |