Failed Dissolution Specifications: low out of specification results for dissolution testing.
All Recalls
95,114 total recalls in our database
Desmopressin Acetate Tablets, 0.2 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc. Parisppany, NJ 07054 USA, NDC 0591-2465-01
Teva Pharmaceuticals USA
GMP Deviations: Product bottle may be absent of desiccant.
Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
AAMI 3 NONREIN SCRBNURGOWN BNS L, Item Code 90270NB
Cardinal Health
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System Catalog Number: 06908349001
Roche Diabetes Care
Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions
AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA
Cardinal Health
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Incomplete seals on the sterile package may compromise the sterility
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011
Clinical Diagnostic Solutions
A mix-up of autosampler tube positions with a possibility of misidentification of sample results and a risk of operator injury from an exposed aspiration needle.
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
The firm become aware of a potentially defective capacitors on circuit boards installed on certain da Vinci Xi, X and SP system Vision Side Carts (VSC) and/or Patient Side Carts (PSC). As a result, you may experience either vision loss or non-recoverable errors 307 or 319, preventing further use of the system.
Centurion- ENT SNUF3 SNUFFER KIT Y
Centurion Medical Products
Incomplete seals on the sterile package may compromise the sterility
AAMI 3 ROYALSILK SURGGOWN BNS XL, Item Code 9548NC
Cardinal Health
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
AAMI 3 FABRIC REINF SURG GOWN XL, Item Code 9541
Cardinal Health
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Centurion- HT5555A HYPERALIMENTATION & DRSG CHG TRAY
Centurion Medical Products
Incomplete seals on the sterile package may compromise the sterility
Centurion- Skin Prep Kits SB1280 SKIN SCRUB KIT SB1525 VAGINAL PREP TRAY
Centurion Medical Products
Incomplete seals on the sterile package may compromise the sterility
Vaginal Verification Panel Ref 8208 Lot 8208-11
Microbiologics
Product 8208 Vaginal Verification Panel is a 6 pool kit and has contaminant Candida krusei in Pool 2 (subcomponent 6063). Candida krusei is an organism intended to be contained in Pool 6 of the kit. This should have no impact on patient test results as long as Gardnerella vaginalis was properly detected when using Pool 2 and/or users are strictly using this product for instrument verification/validation.
The firm become aware of a potentially defective capacitors on circuit boards installed on certain da Vinci Xi, X and SP system Vision Side Carts (VSC) and/or Patient Side Carts (PSC). As a result, you may experience either vision loss or non-recoverable errors 307 or 319, preventing further use of the system.
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.