Labeling: Missing Label
All Recalls
95,025 total recalls in our database
Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC 51672-1259-3
Taro Pharmaceuticals U.S.A.
Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
Lack of Assurance of Sterility
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Failed Dissolution Specifications
The Natural Dentist Healthy Balance Peppermint Sage, Menthol 0.12%, 16.9 FL OZ (500 mL) bottles, Manufactured for Revive Personal Products Company, Madison, NJ 07940, UPC 7 14132 00071 4
Revive Personal Products Company
Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Menthol with UPC 7 14132 00071 4 instead of Peppermint Oil and Sage Oil with UPC 7 14132 00073 8
Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose Vials, 10 vials per carton, Rx Only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0703-1153-03.
Teva Pharmaceuticals USA
Lack of Assurance of Sterility
Metoprolol Tartrate Tablets, USP 25 mg, 1000 - count bottle, Rx Only, Distributed by: TruPharma, LLC. Tampa, FL 33609; Manufactured by: Rubicon Research Prvate Limited Ambernath, Dist. Thane, 421506 India. NDC 52817-360-00
Rubicon Research Private Limited
Complaint received of foreign matter (metal) embedded in tablet.
SOMATOM Edge Plus-Computed tomography system Model 1026700
Siemens Medical Solutions USA
Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
Product is labeled as non-pyrogenic but endotoxin testing was not performed.
GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
DePuy Orthopaedics
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
DePuy Orthopaedics
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.
Technomed Europe
There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining in the patient's scalp.
SOMATOM Definition AS-Computed tomography system Model 8098027
Siemens Medical Solutions USA
Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
SOMATOM Definition Edge -Computed tomography system Model 10590000
Siemens Medical Solutions USA
Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
(1)Start-up problem: Intermittently at start-up of the system, the communication of the control unit that manages the movement of the stand is not established; (2) Emergency stop recovery problem-warm restart is not executed correctly and movement functionality is not available
This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads.
Kits lacks rubber latex warning label.
Increase in premature device failures