FDA recalls, June 2016: 367 published

118 different companies appear this month.

Risk classification: Class I: 94 · Class II: 255 · Class III: 18

Same month, other agencies:CPSC 27 recallsFSIS 11 recallsNHTSA 116 recalls

Recalls this month

DateProduct
June 8, 2016Fruit Tartlets, lemon flavor, 9 - 0.53oz (15 g) tartlets - Net Wt. 4.8 oz (135 g). Manuf…F-1419-2016Ouhlala Gourmet Llc
June 8, 2016Ceftriaxone 1 gram Add-Vantage in a) 50 mL and b) 100 mL 0.45% NS bags, FOR IV USE ONLY, …D-0916-2016Baptist Health Medical Towers Pharmacy and Infusion Services
June 8, 2016Piperacillin-Tazobactam 9 grams/NS 302 mL bags, FOR IV USE ONLY, Baptist Health Medical T…D-0933-2016Baptist Health Medical Towers Pharmacy and Infusion Services
June 8, 2016Ceftriaxone 2 gram Add-Vantage in 100 mL 0.45% NS bag, FOR IV USE ONLY, Baptist Health Me…D-0917-2016Baptist Health Medical Towers Pharmacy and Infusion Services
June 8, 2016Vancomycin 1250 mg in 250 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers…D-0944-2016Baptist Health Medical Towers Pharmacy and Infusion Services
June 8, 2016COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular reconstruct…Z-1840-2016Baxter Healthcare Corp
June 8, 2016Integra MicroFrance Monopolar and Bipolar Electrosurgical InstrumentsZ-1866-2016Integra LifeSciences Corp.
June 8, 2016Clindamycin 900 mg in 100 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers …D-0919-2016Baptist Health Medical Towers Pharmacy and Infusion Services
June 8, 2016TPN 1, (amino acid 20%) 2000 ml bag (140), FOR IV USE ONLY, Baptist Health Medical Towers…D-0938-2016Baptist Health Medical Towers Pharmacy and Infusion Services
June 8, 2016Endoscope ED-250XL5 Operations Manual: Cleaning, DisinfectionZ-1861-2016Fujifilm Medical Systems U.S.A., Inc.
June 8, 2016Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 36" (20.3 cm x 91.4 cm Item …Z-1853-2016Covidien LLC
June 8, 2016EZ Slide Battery/line powered hydraulic table with removable leg section and 21 top slid…Z-1844-2016Skytron, Div. The KMW Group, Inc
June 8, 2016Deferoxamine 4 grams/NS 101 mL Cassette, FOR SUBCUTANEOUS USE ONLY, Baptist Health Medica…D-0923-2016Baptist Health Medical Towers Pharmacy and Infusion Services
June 8, 2016Vancomycin 1000 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers …D-0943-2016Baptist Health Medical Towers Pharmacy and Infusion Services
June 8, 2016Vistec X-Ray Detectable Sponges, 16 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7319Z-1858-2016Covidien LLC
June 8, 2016Deferoxamine 2 grams/51 mL NS cassette, FOR SUBCUTANEOUS USE ONLY, Baptist Health Medical…D-0922-2016Baptist Health Medical Towers Pharmacy and Infusion Services
June 8, 2016Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 12" x 12" (30.5 cm x 30.5 cm…Z-1855-2016Covidien LLC
June 8, 2016Piperacillin-Tazobactam 13.5 grams/NS 322 mL bag, FOR IV USE ONLY, Baptist Health Medical…D-0935-2016Baptist Health Medical Towers Pharmacy and Infusion Services
June 8, 2016The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic steroid, in …Z-1865-2016Abbott Laboratories
June 8, 2016Nafcillin 3 grams in 277 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers P…D-0931-2016Baptist Health Medical Towers Pharmacy and Infusion Services
June 8, 2016Ertapenem 1 gram Add-Vantage in a) 50 mL and b) 100 mL 0.45% NS bag, FOR IV USE ONLY, Bap…D-0926-2016Baptist Health Medical Towers Pharmacy and Infusion Services
June 8, 2016Dimension Vista 1500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V…Z-1886-2016Siemens Healthcare Diagnostics Inc.
June 8, 2016Fruit Tartlets, Raspberry flavor, 9 - 0.56oz (16 g) tartlets - Net Wt. 5.1oz (145 g). Ma…F-1420-2016Ouhlala Gourmet Llc
June 8, 2016Vistec X-Ray Detectable Sponges, 26 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7321Z-1859-2016Covidien LLC
June 8, 2016PASTA SALAD ING: PASTA, ITALIAN DRESSING, DRY ONIONS, PARSLEY, RED PEPPERS, PARMESON CHEE…F-1316-2016Frank L Harter & Sons Inc
June 8, 2016Cefazolin 6 grams in 292 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers …D-0915-2016Baptist Health Medical Towers Pharmacy and Infusion Services
June 8, 2016Vancomycin 1 grams in 250 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers…D-0947-2016Baptist Health Medical Towers Pharmacy and Infusion Services
June 8, 2016Ceftriaxone for Injection USP, 500 mg, Single Use Vial, packaged in a) 1-count Vials per …D-0952-2016Lupin Pharmaceuticals Inc.
June 8, 2016Water for Injection 1000 mL Bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy…D-0940-2016Baptist Health Medical Towers Pharmacy and Infusion Services
June 8, 2016Dimension Vista 500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.…Z-1885-2016Siemens Healthcare Diagnostics Inc.
June 8, 2016Hydromorphone 2 mg/mL (500 mg in 250 mL NS) bag, FOR IV USE ONLY, Baptist Health Medical …D-0927-2016Baptist Health Medical Towers Pharmacy and Infusion Services
June 1, 2016American Surgical Delicot 10 mm x 13 mm Ref Number: 63-03 Product Usage: Neurosurgical…Z-1780-2016American Surgical Company
June 1, 2016PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femora…Z-1814-2016Biomet, Inc.
June 1, 2016Bobo's Oat Bars, Gluten Free, Lemon Poppyseed, Net Weight 3 oz (85g), packaged in clear p…F-1403-2016Simply Delicious Inc.
June 1, 20168.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50 mL, Rx o…D-0865-2016Hospira Inc.
June 1, 2016Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA0…Z-1720-2016Accriva Diagnostics Inc., dba ITC, dba Accumetrics
June 1, 2016AA USA Trading Inc. Ginger Slice Net Wt: 8 oz., AA USA Trading Inc. 47 Reid St. South R…F-1321-2016AA USA Trading Inc.
June 1, 2016Zinc Oxide Powder (API) used in the manufacturing of dietary supplements .F-1402-2016Zochem Inc.
June 1, 20163.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S Product Usage: Usage…Z-1709-2016Synthes (USA) Products LLC
June 1, 2016SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Sh…Z-1711-2016Limacorporate S.p.A
June 1, 2016Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566. Intended for…Z-1704-2016Leica Microsystems, Inc.
June 1, 2016Chlorhexidine gluconate, oral rinse, 0.12% packaged in 16 fl. oz. (473 mL) PET bottle, Rx…D-0875-2016Akorn, Inc.
June 1, 20160.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose C…D-0862-2016Baxter Healthcare Corp.
June 1, 2016American Surgical Americot Blue 3/8" x 2" Ref Number: 20-26S Product Usage: Neurosurgi…Z-1732-2016American Surgical Company
June 1, 2016PerioRx (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET…D-0876-2016Akorn, Inc.
June 1, 2016Man King, packaged in BIG BOX (8 small boxes / 5 capsules per box / 40 capsules), Distrib…D-0901-2016R Thomas Marketing, LLC
June 1, 2016Pink Bikini capsules, (all colors and all strengths), packaged in 30-count bottle, Manufa…D-0882-2016Lucy's Weight Loss (dba. Waisted With Lucy)
June 1, 2016American Surgical Telfa 3/4" x 3" Ref Number: 80-11 Product Usage: Neurosurgical and…Z-1804-2016American Surgical Company
June 1, 2016Zhong Hua Niu Bian, packaged in BIG BOX (6 small boxes / 6 capsules per box / 36 capsules…D-0892-2016R Thomas Marketing, LLC
June 1, 2016Night Man, packaged in SMALL BOX (6 capsules), Distributed by: R Thomas Marketing, LLC, B…D-0903-2016R Thomas Marketing, LLC

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