Drug and pharmaceutical recalls
17732 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-DrugBaxter Healthcare Corp.Class ICLINIMIX 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 IMetronidazole 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 I0.9% 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 II0.9% 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 ILIPO 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 Product found to be tainted with sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, and diclofenac, a prescription non-steroidal anti-inflammatory drug, making this an unapproved drug.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 IAmikacin 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 IISclerosol 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 IIZoloft (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 IIIcol-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 IIRenovo 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 IIIMagnesium 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 IIBETTER 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 IIBrevibloc 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 IIScreenses 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
- 2016-05-18FDA-DrugSesderma, SLClass IIScreenses Color Sunscreen Tinted facial make-up compact, Broad Spectrum SPF 50, Brown, 0.35 oz (10 g), Manufactured by Sesderma S.L., Valencia, Spain, UPC 8 429979 252166
cGMP Deviations; product does not comply with cGMP requirements
- 2016-05-18FDA-DrugSesderma, SLClass IIRepaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Facial Sunscreen gel cream, Broad Spectrum SPF 30, 1.7 fl oz (50 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0010-1
cGMP Deviations; product does not comply with cGMP requirements
- 2016-05-18FDA-DrugSesderma, SLClass IIRepaskin 50 (octocrylene 7%, titanium oxide 2%) Facial Sunscreen gel cream, Broad Spectrum SPF 50, 1.7 fl oz (50 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0011-1
cGMP Deviations; product does not comply with cGMP requirements
- 2016-05-18FDA-DrugSesderma, SLClass IIDryses Aluminum Chlorohydrate Deodorant for Women, Roll-on, 2.5 fl oz (75 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 16047-0029-1
cGMP Deviations; product does not comply with cGMP requirements
- 2016-05-18FDA-DrugSesderma, SLClass IIDryses Aluminum Chlorohydrate Deodorant for Men Roll-on, 2.5 fl oz (75 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0019-1 UPC 8 470002 075221
cGMP Deviations; product does not comply with cGMP requirements
- 2016-05-18FDA-DrugSesderma, SLClass IIRepaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 30, 6.8 fl oz (200 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0012-1 UPC8 429979 415691
cGMP Deviations; product does not comply with cGMP requirements
- 2016-05-18FDA-DrugSesderma, SLClass IIRepaskin 50 (octocrylene 7%, titanium dioxide 2%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 50, 6.8 fl oz (200 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0013-1, UPC 8 429979 415707
cGMP Deviations; product does not comply with cGMP requirements
- 2016-05-18FDA-DrugSesderma, SLClass IISalises Facial Moisturizing Acne Treatment Gel, (salicylic acid 1.5%), 1.7 fl. oz (50 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain --- NDC 63181-0016
cGMP Deviations; product does not comply with cGMP requirements
- 2016-05-18FDA-DrugSesderma, SLClass IIDryses Aluminum Chlorohydrate Antiperspirant Solution, 3.4 fl. oz (100 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0015-1, UPC 8 470003 244268
cGMP Deviations; product does not comply with cGMP requirements
- 2016-05-18FDA-DrugDr. Reddy's Laboratories, Inc.Class IIOndansetron Tablets USP, 4 mg, 30 count bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories, Bachupally, India --- NDC 56111-153-30
Failed Impurities/Degradation Specifications; 12 month stability time point
- 2016-05-18FDA-DrugMylan Pharmaceuticals Inc.Class IIPaliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-3978-93
Failed Dissolution Specifications; three month stability time point.
- 2016-05-11FDA-DrugA-S Medication Solutions LLC.Class IIIAcetaminophen & Codeine Phosphate Tablets, 300 mg/30 mg, 15-count plastic bottle, Rx only, Mfr: Aurolife Pharma LLC, Dayton NJ, Packaged Exclusively by: A-S Medication Solutions LLC, Libertyville, ILL 60048, NDC 54569-8305-0
Labeling: Not elsewhere classified - count on the label was incorrect.
- 2016-05-11FDA-DrugVistaPharm, Inc.Class IIOxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL (1mg/ml) (NDC 66689-401-01), shrink- wrapped in 10 unit dose cups x 5 trays per case (NDC 66689-401-50), Rx only, Manufactured by VistaPharm, Largo, FL 33771
Defective Container: Excess lidding material accumulation between the seal and the cup resulting in the lid not properly adhering and allowing leakage.
- 2016-05-11FDA-DrugBryant Ranch Prepack Inc.Class IIIVenlafaxine 75 mg Tablet, Compare to Effexor 75 mg Tablet, a) 30-count bottle (NDC 636290-3324-2), b) 100-count bottle (NDC 63629-3324-6), Rx Only, Manufactured by Teva Pharmaceuticals USA, Inc. Packaged by Bryant Ranch.
Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release tablets for repackaging, but labeled it incorrectly as the immediate release formulation.
- 2016-05-11FDA-DrugHospira Inc.Class IIIQuelicin (Succinylcholine Chloride) Injection, USP 200 mg. (20 mg/mL), 10 mL Multiple-dose vial, packaged in 25 Unit vials per carton, Rx only, HOSPIRA, INC., LAKE FOREST, IL 60045 USA, NDC 0409-6629-02
Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiration date to be faded or missing from the primary label on the glass vial.
- 2016-05-11FDA-DrugAkorn, Inc.Class IIGood Neighbor Pharmacy PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%), 15 ml bottle, Distributed by AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087, NDC 46122-199-05, ALSO labeled as Premier Value Brand PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%), 15 ml bottle, Distributed by Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-0404-00.
Presence of Particulate Matter
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