Drug and pharmaceutical recalls
17730 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2018-02-07FDA-DrugMedline Industries IncClass IIMedline Wound Closure Tray, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
- 2018-02-07FDA-DrugMedline Industries IncClass IIMedline Sheath Removal Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60063
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
- 2018-02-07FDA-DrugMedline Industries IncClass IIMedline I&D Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
- 2018-02-07FDA-DrugMedline Industries IncClass IIMedline Incision and Drainage Tray Kit, Sterile, Single use only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
- 2018-02-07FDA-DrugMedline Industries IncClass IIMedline Central Line Dressing Change Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
- 2018-02-07FDA-DrugMedline Industries IncClass IIMedline IV Start Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
- 2018-02-07FDA-DrugMedline Industries IncClass IIMedline Suture Removal Tray. Sterile. Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
- 2018-02-07FDA-DrugMedline Industries IncClass IIMedline TRAY, CATHETER CARE, LIDDED. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
- 2018-02-07FDA-DrugMedline Industries IncClass IIMedline Trunk Kit, Non-sterile. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
- 2018-02-07FDA-DrugMedline Industries IncClass IIMedline CNTRL Line Removal Kit Scripps. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
- 2018-02-07FDA-DrugMedline Industries IncClass IIMedline Pediatric IV Kit. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
- 2018-02-07FDA-DrugMedline Industries IncClass IIMedline Concordia Nurse Bag Kit. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
- 2018-02-07FDA-DrugMedline Industries IncClass IIMedline Concordia Trunk Kit. Packaged for Medline Industries, Inc., Northfield, IL 60093
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
- 2018-02-07FDA-DrugMedline Industries IncClass IIMedline Newborn Kit. Packaged for Medline Industries, Inc., Northfield, IL 60093
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
- 2018-02-07FDA-DrugMedline Industries IncClass IIMedline RAD NECK ENT TRAY Pack, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
- 2018-02-07FDA-DrugMedline Industries IncClass IIMedline Vitrectomy CDS Pack, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
- 2018-02-07FDA-DrugMedline Industries IncClass IIMedline Vaginal Delivery CDS Pack, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
- 2018-02-07FDA-DrugMedline Industries IncClass IIMedline CC Drawer 4 IV Circulation Pack, Contains Rx, Single Use Only, contains 2 Prep Pad PVPs. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
- 2018-02-07FDA-DrugMedline Industries IncClass IIAplicare Povidone-Iodine Prep Pad, Antiseptic, Sterile Solution, Active Ingredient: Povidone-iodine USP 10%. Aplicare, INC., Meriden, CT 06450 USA. NDC: 52380-0111-1
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
- 2018-02-07FDA-DrugPremier Pharmacy Labs IncClass IIMitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV , Compounded by: Premier Pharmacy Labs 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-160-35.
Labeling: Label Error on Declared Strength
- 2018-02-07FDA-DrugTaro Pharmaceuticals U.S.A., Inc.Class IIIClobetasol Propionate Cream USP, 0.05% 60 g tube, Rx only Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761 Dist. by : Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532 UPC 351672125837 NDC 51672-1258-3
Failed Content Uniformity Specifications
- 2018-02-07FDA-DrugAscent Pharmaceuticals, Inc.Class IIIOxycodone Hydrochloride Tablets, USP 15 mg, 100 count bottles, Rx only, Manufactured for Camber Pharmaceuticals, Inc., Piscataway, NJ, Manufactured by: Ascent Pharmaceuticals, Inc., Central Islip, NY --- NDC 31722-917-01
Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol
- 2018-02-07FDA-DrugBlue Fusion NaturalClass IBLUE PEARL capsules, 500mg, 1-count packets, Distributed by Blue Pearl Long Beach, CA UPC 8 4704600978 5
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.
- 2018-02-07FDA-DrugJCB Laboratories LLCClass IIICefuroxime, Ophthalmic Solution for Injection, 10 mg/mL, 0.3 mL single-use syringe. This is a Compounded Drug, Hospital & Office Use Only, Not for Resale. Fagron Sterile Services/JCB Laboratories, 7335 W. 33rd St. N., Wichita, KS 67205
Subpotent Drug: The product is sub-potent prior to its 90-day beyond use date.
- 2018-02-07FDA-DrugJohnson & JohnsonClass IINeutrogena Elevated 4-Holiday Trays (contains Neutrogena Deep Clean Purifying Whipped Foam Cleanser) Case Code: 00070501302866
Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area.
- 2018-02-07FDA-DrugJohnson & JohnsonClass IINeutrogena deep clean purifying whipped foam cleanser, (Salicylic Acid 0.5%), aerosolized product in a can, NET WT. 5 OZ. (141 g) Distributed By: Johnson & Johnson Consumer Inc. Skillman, NJ 08558. UPC: 0 70501 10053 0
Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area.
- 2018-02-07FDA-DrugJohnson & JohnsonClass IINeutrogena Acne Proofing whipped foam cleanser, (Salicylic Acid 2%), aerosolized product in a can, NET WT. 5 OZ (141 g) , Distributed by Johnson & Johnson Consumer Inc. Skillman, NJ 08558, UPC 0 70501 11131 4
Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area.
- 2018-02-07FDA-DrugBoehringer Ingelheim Pharmaceuticals, Inc.Class IISPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90 capsules (unit dose blisters) per box, Rx Only, Made in Germany, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877, NDC 0597-0075-47
Failed Stability Specifications
- 2018-01-31FDA-DrugAdvanced Pharma Inc.Class IMAGnesium 2 gm in NS 100 mL Magnesium SULfate (USP) 0.9% Sodium Chloride (USP) in 100 mL Sterile single dose bag, Rx only, Avella of Houston 9265 Katy Dr., Houston, TX ---NDC 42852-907-10
Subpotent
- 2018-01-31FDA-DrugBotanicalNowClass IBodySlim Herbal Advanced technology & Strong formula capsules, 400 mg, 30-count bottle, Barcode: 9567153432481
Marketed without an approved NDA/ANDA: FDA analysis found the product to contain undeclared sibutramine.
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