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FDA Drug Recalls

18043 recall notices on file. Class I recalls involve a reasonable probability of serious adverse health consequences or death.

ProductFirmClassificationStatusReport date
EPINEPHrine (USP) 4 mg, 5% Dextrose For Inj. (USP) 250 mL Volume: 254 mL single dose bag. For: Peninsular Regional Medical Center. By: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054. NDC 15082-855-25. Avella of Deer Valley, Inc. Store 38 Class II Terminated 20180725
ePHEDrine 50mg, 50 mg/10 mL (5 mg per mL) (Ephedrine Sulfate, USP 50mg in 0.9% Sodium Chloride, USPQS 10mL. 10 mL-Sterile use dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-805-61 Avella of Deer Valley, Inc. Store 38 Class II Terminated 20180725
ceFAZolin 2 gm in NS 100mL. ceFAZolin Sodium (USP) 2gm, 0.9% Sodium Chloride (USP) 100mL. Volume 110 mL. Single dose bag. Avella of Houston 9265 Kirby Dr., Houston, TX 77054 NDC: 42852-604-10 Avella of Deer Valley, Inc. Store 38 Class II Terminated 20180725
0.2% ROPivacaine - OnQ Pump, (ROPivacaine HCL (USP) 1100mg, 0.9% Sodium Chloride (USP) QS 550 ml, single dose pump. For: Vidant Medical Center, By: Avella of Houston, 9265 Kirby Dr., Houston, TX 77056. NDC: 42852-661-02 Avella of Deer Valley, Inc. Store 38 Class II Terminated 20180725
Metformin Hydrochloride Extended Release Tablets, USP, 500 mg, packaged in a 500-count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350 Gujarat. India, NDC 62756-142-02 Sun Pharmaceutical Industries, Inc. Class II Terminated 20180725
Glutathione 200mg/mL Injection w/Pres. (Benzyl Alcohol 1.5% in Sterile Water), 30 mL vial, Rx only, la VITA Compounding Pharmacy, 858.453.2500 La Vita Compounding Pharmacy, LLC Class II Terminated 20180725
Methyl Folate CA+ 1mg/ml Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), 10 mL and 30 mL vials, Rx only, la VITA Compounding Pharmacy, 858.453.2500 La Vita Compounding Pharmacy, LLC Class II Terminated 20180725
Methylcobalamin 1mg/mL Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), packaged in 10 mL and 30 mL vials, Rx only, la VITA Compounding Pharmacy, 858.453.2500 La Vita Compounding Pharmacy, LLC Class II Terminated 20180725
alba BOTANICA sport mineral sunscreen (titanium dioxide 7.0% and zinc oxide 9.0%), spf 45, 170 g (6 oz) tubes packaged in a) 4 tubes per case; b) 8 pack shipper display; Manufactured By: The Hain Celestial Group, Inc., Lake Success, NY 11042, UPC 7 24742 01102 4. The Hain Celestial Group, Inc. - Worldwide HQ Class II Terminated 20180725
Piperacillin and Tazobactam for Injection USP 3.375 grams per vial, Single-Dose Vial, Rx Only. Manufactured for: Auromedics Pharma LLC 6 Wheeling Road Dayton NJ 08810, Made in India. NDC 55150-120-30 AuroMedics Pharma LLC Class I Terminated 20180718
Gaia Kratom (mitragyna speciosa) powder, Yellow Vietnam, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Gaia Ethnobotanical LLC Class I Terminated 20180718
Gaia Kratom (mitragyna speciosa) powder, Yellow Thai, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Gaia Ethnobotanical LLC Class I Terminated 20180718
Gaia Kratom (mitragyna speciosa) powder, White Thai, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Gaia Ethnobotanical LLC Class I Terminated 20180718
Gaia Kratom (mitragyna speciosa) powder, White MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Gaia Ethnobotanical LLC Class I Terminated 20180718
Gaia Kratom (mitragyna speciosa) powder, White Horn, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Gaia Ethnobotanical LLC Class I Terminated 20180718
Gaia Kratom (mitragyna speciosa) powder, White Borneo, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Gaia Ethnobotanical LLC Class I Terminated 20180718
Gaia Kratom (mitragyna speciosa) powder, Red MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Gaia Ethnobotanical LLC Class I Terminated 20180718
Gaia Kratom (mitragyna speciosa) powder, Red Kapuas Hulu , 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Gaia Ethnobotanical LLC Class I Terminated 20180718
Gaia Kratom (mitragyna speciosa) powder, Red Horn, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Gaia Ethnobotanical LLC Class I Terminated 20180718
Gaia Kratom (mitragyna speciosa) powder, Red Dragon, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Gaia Ethnobotanical LLC Class I Terminated 20180718
Gaia Kratom (mitragyna speciosa) powder, Red Borneo, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Gaia Ethnobotanical LLC Class I Terminated 20180718
Gaia Kratom (mitragyna speciosa) powder, Red Bali, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Gaia Ethnobotanical Red Borneo, 1oz, 250g, kg Gaia Ethnobotanical Red Dragon, 1oz, 250g, 1kg Gaia Ethnobotanical Red Horn, 1oz, 250g, 1kg Gaia Ethnobotanical Red Kapuas Hulu 1oz, 250g, 1kg Gaia Ethnobotanical Red MD, 1oz, 250g, 1kg Gaia Ethnobotanical Red Thai, 1oz, 250g,. 1kg Gaia Ethnobotanical Super Green Malay 1oz, 250g, 1kg Gaia Ethnobotanical White Borneo 1oz, 250g, 1kg Gaia Ethnobotanical White Horn, 1 oz, 250g, 1kg Gaia Ethnobotanical White MD, 1 oz, 250 g, 1 kg Gaia Ethnobotanical White Thai, 1oz, 250 g, 1 kg Gaia Ethnobotanical Yellow Thai, 1oz, 250 g, 1kg Gaia Ethnobotanical Yellow Vietnam 1oz, 250g, 1kg Gaia Ethnobotanical LLC Class I Terminated 20180718
Gaia Kratom (mitragyna speciosa) powder, Purple 8-1, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Gaia Ethnobotanical LLC Class I Terminated 20180718
Gaia Kratom (mitragyna speciosa) powder, Plantation White MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Gaia Ethnobotanical LLC Class I Terminated 20180718
Gaia Kratom (mitragyna speciosa) powder, Plantation Red MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Gaia Ethnobotanical LLC Class I Terminated 20180718
Gaia Kratom (mitragyna speciosa) powder, Green Thai, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Gaia Ethnobotanical LLC Class I Terminated 20180718
Gaia Kratom (mitragyna speciosa) powder, Green MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Gaia Ethnobotanical LLC Class I Terminated 20180718
Gaia Kratom (mitragyna speciosa) powder, Green Malay, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Gaia Ethnobotanical LLC Class I Terminated 20180718
Gaia Kratom (mitragyna speciosa) powder, Green Kapuas Hulu, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Gaia Ethnobotanical LLC Class I Terminated 20180718
Gaia Kratom (mitragyna speciosa) powder, Green Horn, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Gaia Ethnobotanical LLC Class I Terminated 20180718
Gaia Kratom (mitragyna speciosa) powder, Green Dragon, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Gaia Ethnobotanical LLC Class I Terminated 20180718
Gaia Kratom (mitragyna speciosa) powder, Ganesh, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Gaia Ethnobotanical LLC Class I Terminated 20180718
Gaia Kratom (mitragyna speciosa) powder, Elephant, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Gaia Ethnobotanical LLC Class I Terminated 20180718
Gaia Kratom (mitragyna speciosa) powder, Bali Gold, 1oz, 250g 1kg packages, Gaia Ethnobotanical.com Gaia Ethnobotanical LLC Class I Terminated 20180718
Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals, Inc. Morgantown, WV 26505, NDC 0378-1352-01 Mylan Pharmaceuticals Inc. Class III Terminated 20180718
Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, UPC 343386-450-114, NDC 43386-450-11 LUPIN SOMERSET Class II Terminated 20180718
Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection, packaged in 3mL prefilled pens, 1 pen per box, Rx only, Physician Sample - Not For Sale, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807, NDC 0024-5925-00 Sanofi-Aventis U.S. LLC Class II Ongoing 20180718
Potassium Chloride For Injection Concentrate syringe 40 mEq/20 mL (2 mEq/mL), Rx only, Medi-Fare Drug Pharmaceutical Compounding 300 West Pine St., Blacksburg, SC 29702 800-622-0007 Medi-Fare Drug and Home Health Center Class II Terminated 20180718
Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use (Concentration=10 mg/mL) 0.25 mL Total Volume, Rx only , SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205 877-550-5059 SCA Pharmaceuticals Class II Terminated 20180718
Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 12 applicators, 8 mL per box, Manufactured For: MedGyn Products, Inc., 100 W. Industrial Rd., Addison, IL 60101 USA; Manufactured By: BioDiagnostics Intl, 555 West Lambert Road Unit-C, Brea, CA 92821, NDC 42721-112-08. Medgyn Products, Inc. Class II Terminated 20180718
Acetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only. Manufactured by Akron Inc., Lake Forest, IL 60045. NDC 17478-660-30. Akorn, Inc. Class II Terminated 20180718
Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 cartons in a shipper, Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-390-01 Carton [68084-390-11 - Unit Dose] AMERICAN HEALTH PACKAGING Class III Terminated 20180718
Enalapril Maleate Tablets USP; 2.5 mg NDC code 64679-923-03. 1000 Tablets HDPE container pack with Non CRC cap and 2 desiccants further packed in E-flute cartons. Wockhardt Limited Class III Terminated 20180718
Enalapril Maleate Tablets USP; 5 mg NDC code 64679-924-03. 1000 Tablets HDPE container pack with Non CRC cap and 2 desiccants further packed in E-flute cartons. Wockhardt Limited Class III Terminated 20180718
Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108 USA; Distributed by: Actavis Pharmac, Inc., Parsippany, NJ 07054 USA, NDC 0591-2990-60. Teva Pharmaceuticals USA Class II Terminated 20180718
Neostigmine Methylsulfate Injection Solution, 3 mg per 3 mL, 1 mg per mL, 3 mL prefilled syringe, 5 syringes per package, Rx only, Fagron Sterile Services, ICB Laboratories, 8710 E 34th St. N., Wichita, KS 67205, NDC 71266-2003-01. Fagron Compounding Services LLC dba Fagron Sterile Services Class I Terminated 20180711
Neostigmine Methylsulfate Injection Solution, 5 mg per 5 mL, 1 mg per mL, 5 mL prefilled syringe, 5 syringes per package, Rx only, Fagron Sterile Services, ICB Laboratories, 8710 E 34th St. N., Wichita, KS 67205, NDC 71266-2003-02. Fagron Compounding Services LLC dba Fagron Sterile Services Class I Terminated 20180711
eb5 Skincare that Works. Age Spot Treatment. Skin Lightening Cream with 2% Hydroquinone. 177.4 ml / 6 fl oz carton containing a tube. Manufactured For: EB5 Corporation Portland, OR 97210 Carton Bar Code: 7 41099 00009 9 Eb5 Corporation Class II Terminated 20180711
Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution, OS Osmotic Laxative, OTC, packaged in a) 119 g bottle (NDC 49035-312-07), b) 238 g bottle (NDC 49035-312-08), Distributed by: Wal-mart Stores, Inc., Bentonville, AR 72716 LUPIN SOMERSET Class III Terminated 20180711
Phenylephrine HCL 80mg in 0.9% Sodium Chloride 250 mL Bag (320 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT SCA Pharmaceuticals, LLC Class II Terminated 20180711