Zoma Shampoo, Zinc Pyrithione 1.92%, 300 ml/10.01 fl. oz. bottles, Dermatologic Cosmetic Laboratories, East Haven, CT
Milbar Laboratories
💊 Drugs Class I - Dangerous
Subpotent
All Recalls
95,075 total recalls in our database
0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10.
Fresenius Medical Care Renal Therapies Group
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
💊 Drugs Class I - Dangerous
Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac Sodium and Misoprostol 50 mg/0.2 mg tablets.
PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg, Rx Only, 48-count bottle, NDC 00378-4710-22
Mylan Pharmaceuticals
💊 Drugs Class I - Dangerous
CGMP Deviations
PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets, 30 mg, Rx Only, 48-count bottle, NDC 00378-4730-22
Mylan Pharmaceuticals
💊 Drugs Class I - Dangerous
CGMP Deviations
Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC 51079-902-20
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
💊 Drugs Class I - Dangerous
GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
💊 Drugs Class I - Dangerous
CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01
Mylan Pharmaceuticals
💊 Drugs Class I - Dangerous
CGMP Deviations
Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module electronics. The failure mode may result in a Voltage Out of Range malfunction alarm, which causes the device to enter a safe state and become inoperable until it is serviced. Baxter will be releasing new firmware that will prevent the malfunction from occurring.
🏥 Medical Devices Class I - Dangerous
Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used beyond the expiration date,
Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module electronics. The failure mode may result in a Voltage Out of Range malfunction alarm, which causes the device to enter a safe state and become inoperable until it is serviced. Baxter will be releasing new firmware that will prevent the malfunction from occurring.
🏥 Medical Devices Class I - Dangerous
The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
Omega LIF interbody implants labeled as having 11 degrees of lordosis was assembled using components manufactured with 4 degrees of lordosis.
Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module electronics. The failure mode may result in a Voltage Out of Range malfunction alarm, which causes the device to enter a safe state and become inoperable until it is serviced. Baxter will be releasing new firmware that will prevent the malfunction from occurring.
First Step Endoscopic Cleaning Pad, 100ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-3
Madison Polymeric Engineering
🏥 Medical Devices Class I - Dangerous
The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.
Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used in systems indicated for fracture fixation.
Synthes (USA) Products
🏥 Medical Devices Class I - Dangerous
The adapter may demonstrate a degradation of function as the final products were assembled with ball bearings of high carbon content that is likely to rust prematurely.
Travel Kit, First Step EP-4 Kit (200 mL) and 1 Soiled Scope Bag (White), Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number TK-200(W)
Madison Polymeric Engineering
🏥 Medical Devices Class I - Dangerous
The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.
First Step Endoscopic Cleaning Pad, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4
Madison Polymeric Engineering
🏥 Medical Devices Class I - Dangerous
The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.
🏥 Medical Devices Class I - Dangerous
The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in the Unique Device Identification (UDI) bar code and readable code just beneath the barcode. Specifically, the expiration date is reported as DDMMYY instead of YYMMDD. The expiration date in the applicable field on the package labels are correct as printed.