Drug and pharmaceutical recalls

17628 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.

2016-06-01FDA-DrugLucy's Weight Loss (dba. Waisted With Lucy)Class I
Shorts on The Beach Strong Formula by Pink Bikini capsules, 750 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010
Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.
2016-06-01FDA-DrugLucy's Weight Loss (dba. Waisted With Lucy)Class I
Pink Bikini Strong Formula capsules, 750 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010
Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.
2016-06-01FDA-DrugCentro NaturistaClass I
Smart Lipo Dietary Supplement capsules, 900 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011
Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and phenolphthalein.
2016-06-01FDA-DrugCentro NaturistaClass I
Smart Lipo Dietary Supplement capsules, 800 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011
Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and phenolphthalein.
2016-06-01FDA-DrugAkorn, Inc.Class II
PerioRx (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for Discus Dental, LLC, Ontario, CA 91761, UPC 4235 020 91701
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
2016-06-01FDA-DrugAkorn, Inc.Class II
Chlorhexidine gluconate, oral rinse, 0.12% packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC., Amityville, NY 11701, NDC 5083-0720-16
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
2016-06-01FDA-DrugAkorn, Inc.Class II
ORIS (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for DENTSPLY Professional, York, PA 17404, UPC D00513003001O
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
2016-06-01FDA-DrugSanofi-Aventis U.S. LLCClass I
Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.15 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0024-5831-02) and (b) 1 prefilled auto injector + 1 trainer (NDC 0024-5831-00), Rx Only, Manufactured for Sanofi-Aventis US, LLC Bridgewater, NJ 08807 A Sanofi Company
Defective Delivery System; potential to have inaccurate dosage delivery
2016-06-01FDA-DrugSanofi-Aventis U.S. LLCClass I
Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.3 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0025-5833-02) and (b) 1 prefilled auto injector + 1 trainer (NDC 0024-5833-00), Rx Only, Manufactured for Sanofi-Aventis US, LLC Bridgewater, NJ 08807 A Sanofi Company
Defective Delivery System; potential to have inaccurate dosage delivery
2016-06-01FDA-DrugPharmakon PharmaceuticalsClass I
Morphine Sulfate 0.5 mg/mL, Preservative Free in 0.9% Sodium Chloride, Rx, total volume 1 mL, This is a compounded drug, CII, IV Use, syringe, Pharmakon Pharmaceuticals, NDC 45183-0322-78.
Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfate Inj.
2016-06-01FDA-DrugPacifico National, Inc. dba AmEx PharmacyClass I
Avastin (Bevacizumab) 1.25 mg/0.05 mL syringe, Office Administration Only, AmEx Pharmacy, 1515 Elizabeth St Suite J, Melbourne, FL 32901.
Non-Sterility: Product tested positive for bacterial contamination.
2016-06-01FDA-DrugPacifico National, Inc. dba AmEx PharmacyClass I
Avastin (Bevacizumab) 2 mg/0.08 mL syringe, Office Administration Only, AmEx Pharmacy, 1515 Elizabeth St Suite J, Melbourne, FL 32901.
Non-Sterility: Product tested positive for bacterial contamination.
2016-06-01FDA-DrugTeva North AmericaClass II
Linezolid Injection, 600 mg/300 mL Single use container bags (NDC 0703-9060-31), packaged in 10 x 300 mL Single Use Container bags per Box Pack (NDC 0703-9060-33), Rx only, Manufactured In Hungary By: Teva Pharmaceutical Works Ltd., Hungary, H-2100 Godollo, Tancsics M. ut 82 Hungary; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454
Lack of Assurance of Sterility: Due to potential for leaking bags.
2016-06-01FDA-DrugFresenius Kabi USA, LLCClass II
OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-04
Failed Impuities/Degradation Specifications
2016-06-01FDA-DrugFresenius Kabi USA, LLCClass II
OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-01.
Failed Impuities/Degradation Specifications
2016-06-01FDA-DrugHospira Inc.Class I
8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50 mL, Rx only, Hospira Inc, Lake Forest, IL 60045, NDC 0409-6625-02
Presence of Particulate Matter: particulate matter identified as an insect in one vial.
2016-06-01FDA-DrugBaxter Healthcare Corp.Class I
CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose with Calcium) Injection, 1000 mL Injection Port Chamber 30% Dextrose Injection with Calcium, 1000 mL Outlet Port Chamber 10% Amino Acid Injection with Electrolytes, 2000 mL CLARITY Dual Chamber Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B7721, NDC 0338-1123-04.
Presence of Particulate Matter: identified as dried skin.
2016-06-01FDA-DrugBaxter Healthcare Corp.Class I
Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Single Dose Container bag, Rx only, Baxter USA, Product Code 2B3421, NDC 0338-1055-48.
Presence of Particulate Matter: identified as a cloth fiber.
2016-06-01FDA-DrugBaxter Healthcare Corp.Class I
0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-18.
Presence of Particulate Matter: identified as cardboard.
2016-06-01FDA-DrugBaxter Healthcare Corp.Class II
0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-18.
Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of sterility.
2016-06-01FDA-DrugLipo Escultura Corp.Class I
LIPO ESCULTURA capsules, 250 mg, 60-count bottles, Distributed By: JAT Productos Naturales Corp., BROOKLYN, NY 11238, www.lipoesculturatreatment.com
Marketed Without An Approved NDA/ANDA: Tainted product marketed as a dietary supplement. Product found to be tainted with sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, and diclofenac, a prescription non-steroidal anti-inflammatory drug, making this an unapproved drug.
2016-06-01FDA-DrugTeva Pharmaceuticals USAClass I
Amikacin Sulfate injection USP,1 gm/4 mL (250 mg/mL) 4mL vial, Rx only, Manufactured in Hungary For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454. Individual Pack NDC 0703-9040-01, Shelf Pack NDC 0703-9040-03
Presence of Particulate Matter: particulate matter identified as glass in one vial.
2016-06-01FDA-DrugLymol MedicalClass II
Sclerosol Intrapleural Aerosol (sterile talc powder), Intrapleural administration, 4 g Canister, Rx Only, Distributed by: Bryan Corporation, Woburn, MA 01801, USA, NDC 63256-100-30
Defective Delivery System: Defective stem valve causes leakage of the propellant in the spray canister delivering no drug or an inadequate amount of the drug to be delivered.
2016-06-01FDA-DrugPfizer Inc.Class II
Zoloft (sertraline HCl) tablets, 100 mg*, 30 count bottles, Rx only, Distributed by Roerig, Division of Pfizer, Inc., NY NY 10017, NDC 0049-4910-30.
Failed Tablet/Capsule Specifications: thick tablets exceeding specifications were found.
2016-05-25FDA-DrugAllegiant HealthClass III
col-rite (docusate sodium) stool softener softgels, 50 mg, packaged in a) 30-count, item 351104, UPC 0 11822 51104 9; and b) 60-count, item 357392, UPC 0 11822 57392 4; DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL , PA 17011.
Superpotent Drug: High out of specification results for assay at the 6 month time point interval.
2016-05-25FDA-DrugTMIG IncClass II
Renovo Patch (Capsaicin, 0.0375%, Menthol, USP 5.00%), 3-count patches per carton, Rx only, Distributed By: TMIG Inc, Marietta , GA 30062, Manufactured By: Pocono Coated Products LLC., Cherryville, NC 28021 NDC: 69176-025-03
Marketed Without An Approved NDA/ANDA: product is an unapproved drug and additionally 3 lots were found to be subpotent.
2016-05-25FDA-DrugHospira Inc.Class III
Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 216802 5.
Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.
2016-05-25FDA-DrugKeystone Laboratories IncClass II
BETTER BRAIDS UN-BRAID (salicylic acid), Le Demelant, Packaged in 12 FL. OZ. (355 ml) Bottles, Over the Counter Only. Distributed by KEYSTONE LABORATORIES, UPC 07059600430.
Microbial Contamination of Non-Sterile Products: Failed S.aureus test.
2016-05-18FDA-DrugBaxter Healthcare Corp.Class II
Brevibloc DOUBLE STRENGTH Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2000mg/100mL (20 mg/mL), 100 mL, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, Il 60015, NDC 10019-075-87
Discoloration: presence of atypical yellow discoloration of the solution .
2016-05-18FDA-DrugSesderma, SLClass II
Screenses Color Sunscreen, Tinted facial make-up compact, Broad Spectrum SPF 50 Light, 0.35 oz (10 g), Manufactured by Sesderma S.L., Valencia, Spain, UPC 8 429979 252159
cGMP Deviations; product does not comply with cGMP requirements

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