Severity 1 of 5

Low recalls

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

What “low” means here

Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

1626–1650 of 2769

LowFDA (Drugs)·D-1031-2016·2016-06-22
Galderma Recalls Doxycycline Capsules Due to Missing Lot and Expiration Dates
Galderma Laboratories is recalling Doxycycline USP Capsules 40 mg because some bottles are missing lot numbers or expiration dates.
Product
Doxycycline, USP Capsules 40 mg, Packaged in 30 ct Bottles, Rx Only. Marketed by: Prasco Laboratories, Mason, OH 45040 USA, Manufactured by: Catalent Pharma Solutions, LLC, Winchester, Kentucky 40391. NDC: 66993-815-30.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1034-2016·2016-06-22
Valeant Recalls Librax Capsules Due to Failed Impurity Specifications
Valeant Pharmaceuticals is recalling specific lots of Librax capsules because they failed impurity and degradation specifications.
Product
LIBRAX — LIBRAX (CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1896-2016·2016-06-22
CareFusion Recalls AVEA Ventilators Due to Fuse Failure Risk
CareFusion is recalling AVEA Ventilators because an incorrect fuse may fail, causing loss of power to the user interface module.
Product
Gas Delivery Engine (GDE), 16650A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1948-2016·2016-06-22
Leica Biosystems Recalls Ariol Automated Scanning Microscopes Due to Software Issue
Leica Biosystems Richmond Inc. is recalling 33 Ariol automated scanning microscope systems because a manufacturing error resulted in an improperly activated Windows 7 operating system.
Product
Ariol is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the detection, classification, and counting of cells of interest based on particular color, intensity, size, pattern, and shape. Thi
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0974-2016·2016-06-15
Aidarex Recalls Ceftriaxone for Injection Due to Manufacturing Deviations
Aidarex Pharmaceuticals is recalling Ceftriaxone for Injection due to out-of-specification intermediates during manufacturing.
Product
CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01
Category
Drug
Distribution
2 states
LowFDA (Devices)·Z-1924-2016·2016-06-15
MedComp Recalls Tearaway Introducers Due to Incorrect Expiration Date Labeling
Medical Components, Inc dba MedComp is recalling specific lots of Tearaway Introducers because they are labeled with incorrect expiration dates.
Product
Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490 Product Usage: The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldi
Category
Medical Device
Distribution
3 states
LowFDA (Devices)·Z-1909-2016·2016-06-08
Affymetrix Recalls CytoScan Dx Assay Kits Due to Missing Warning Statements
Affymetrix is recalling 507 CytoScan Dx Assay kits because FDA inspectors found that required warning statements were missing from product shipments.
Product
CytoScan¿ Dx Assay. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a microarray kit, and analysis software. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a microarray kit, and analysis software: MOD R LA, CytoScan¿ Dx P
Category
Medical Device
Distribution
15 states
LowFDA (Drugs)·D-0955-2016·2016-06-08
Lupin Recalls Ceftriaxone Sodium API Due to CGMP Deviations
Lupin Pharmaceuticals Inc. is recalling Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient because intermediates failed specifications.
Product
Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931; Manufactured by: Lupin Limited, Unit-1, 198-202, New Industrial Area No. 2, Dist. Raisen, Mandideep-462 046, (Madhya Pradesh) India; Regd. Office: 159, CST Road Kalina, Santacruz (E), Mumbai- 400 09
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0953-2016·2016-06-08
Lupin Recalls Ceftriaxone Injection Vials Due to CGMP Deviations
Lupin Pharmaceuticals is recalling Ceftriaxone for Injection vials because they were manufactured using active pharmaceutical ingredients that failed specifications.
Product
Ceftriaxone for Injection USP, 1 g, Single Use Vial (NDC 68180-633-01) packaged in 10-count Vials per box (NDC 68180-633-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0952-2016·2016-06-08
Lupin Recalls Ceftriaxone Injection Vials Due to CGMP Deviations
Lupin Pharmaceuticals is recalling Ceftriaxone for Injection USP, 500 mg, because the active ingredients used in manufacturing failed specifications.
Product
Ceftriaxone for Injection USP, 500 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-622-01), and b) 10-count Vials per box (NDC 68180-622-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufact
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0954-2016·2016-06-08
Lupin Recalls Ceftriaxone Injection Vials Due to CGMP Deviations
Lupin Pharmaceuticals is recalling 570 vials of Ceftriaxone for Injection USP, 2 g, because the active pharmaceutical ingredients used in manufacturing failed specifications.
Product
Ceftriaxone for Injection USP, 2 g, Single Use Vial (NDC 68180-644-01) packaged in 10-count Vials per box (NDC 68180-644-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0951-2016·2016-06-08
Lupin Recalls Ceftriaxone Injection Vials Due to CGMP Deviations
Lupin Pharmaceuticals is recalling specific lots of Ceftriaxone for Injection USP because they were manufactured using active pharmaceutical ingredients that failed specifications.
Product
Ceftriaxone for Injection USP, 250 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-611-01), and b) 10-count Vials per box (NDC 68180-611-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufact
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1907-2016·2016-06-08
B. Braun Recalls Non-Vented Dispensing Pins Due to Packaging Tears
B. Braun Medical is recalling 11,000 Non-Vented Dispensing Pins because the outer blister packaging may tear, potentially compromising the device.
Product
Non-Vented Dispensing Pin with Luer Lock Ultrasite Valve Product Usage: Used for aspiration of medication from inverted bags or semi-rigid containers. Interavenous delivery of transferred medication(Device is not intended for direct infusion)
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1906-2016·2016-06-08
B. Braun Medical Recalls Non-Vented Dispensing Pins Due to Packaging Tears
B. Braun Medical is recalling approximately 11,000 Non-Vented Dispensing Pins because the outer blister packaging may tear, potentially compromising the product label.
Product
Non-Vented Dispensing Pin with One-Way Valve and Luer Lock Ultrasite Valve Product Usage: Used for aspiration of medication from inverted bags or semi-rigid containers. Interavenous delivery of transferred medication(Device is not intended for direct infusion)
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1830-2016·2016-06-01
Roche Recalls Hungarian Instructions for cobas EGFR Mutation Test Kits
Roche is recalling 8 kits of cobas EGFR Mutation Test v2 and cfDNA Sample Preparation due to errors in the Hungarian translated instructions for use.
Product
cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian Translation Instructions for Use
Category
Medical Device
Distribution
0 states
LowUSDA FSIS·045-2016·2016-05-27
Burger's Ozark Recalls Pulled Pork Due to Incorrect Back Label
Burger's Ozark Country Cured Hams is recalling approximately 150 pounds of seasoned pulled pork products because the back of the package displays an incorrect label for a beef brisket product.
Product
Burger's Ozark Country Cured Hams, Inc. — Recall Notification Report 045-2016 (Pulled Pork Products)
Category
Food
Distribution
1 state
LowFDA (Drugs)·D-0854-2016·2016-05-25
Hospira Recalls Magnesium Sulfate Injection Due to pH Failures
Hospira Inc. is recalling 715,200 vials of Magnesium Sulfate Injection, USP 50% due to confirmed high out-of-specification pH results.
Product
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.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Food)·F-1333-2016·2016-05-25
Manischewitz Pistachio Orange Macaroons Recalled for Pistachio Shell Fragments
R.A.B. Food Group LLC is recalling Manischewitz Pistachio Orange Macaroons due to potential pistachio shell fragments.
Product
Manischewitz Pistachio Orange Macaroons 10 oz. Distributed by: The Manischewitz Company Newark, NJ 07105 Product of USA UPC 0-7270000119-6
Category
Food
Distribution
6 states
LowFDA (Drugs)·D-0856-2016·2016-05-25
Allegiant Health Recalls Col-Rite Stool Softeners for Potency Issues
Allegiant Health is recalling specific lots of Col-Rite stool softeners because they failed potency tests. Consumers should stop using the product and return it to the pharmacy.
Product
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.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1615-2016·2016-05-18
Siemens ADVIA Centaur CP Immunoassay System Recalled for Documentation Errors
Siemens Healthcare Diagnostics is recalling the ADVIA Centaur CP Immunoassay System because inaccuracies in the Operator's Guide may cause sample processing issues when using EZee-Nest Insert Cups.
Product
ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME: Immunoassay Analyzers. This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnos
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1644-2016·2016-05-18
Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards
Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.
Product
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P643 REF 418671), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylo
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-1645-2016·2016-05-18
Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards
Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.
Product
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P644 REF 418673), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylo
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-1647-2016·2016-05-18
Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards
Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.
Product
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P646 REF 420144), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylo
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-1640-2016·2016-05-18
Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards
Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.
Product
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P639 REF 418662), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphyl
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-1643-2016·2016-05-18
Biomerieux Vitek 2 Gram Positive Test Cards Recalled for Labeling Error
Biomerieux is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.
Product
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 REF 418604), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylo
Category
Medical Device
Distribution
0 states